#usfda approval

[izielhealthcare]

Are you making these mistakes with FDA 21 CFR PART 820 made for medical devices

Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820 This document guides to govern the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices intended for human use. The requirements in 21 CFR Part 820 are meant to ensure the safety and efficacy of medical devices sold in the US marketplace.

FDA conducts regular inspections of medical device manufacturers to ensure compliance with these regulations. The inspection process, known as the Quality System Inspection Technique (QSIT), evaluates a company’s internal quality processes to determine whether they are in alignment with or in violation of these regulatory requirements. If any violations are discovered, the inspecting agent from FDA will issue in the form of 483 Inspectional Observations, Warning Letters what is applicable

 Here are the most common mistakes companies run into with FDA 21 CFR Part 820:

1.  CAPA Procedures and 21 CFR Part 820.100(a) CAPA not followed adequately and repeat failure is detected

2.  Complaint Handling and CFR Part 820.198(a) Parameters described in procedure are not fulfilled and closure is not timely and adequate.

3. Nonconforming Product and CFR Part 820.90(a) Investigation is not proper, CAPA is not applied conclusion is not enough, preventive action is not proper, repeat failure is detected.

4.  Purchasing Controls and CFR Part 820.50 control for specification and artwork s not controlled purchase found with old label artwork and specification. PO does not mention specification or art- work reference

5.  Process Validation and CFR Part 820.75 System is not adequate, not followed, re-validation where defined is not done or done late, changes are not captured in validation. Protocols are not properly and timely approved before starting activities.

6.  Quality Audit and CFR Part 820.22 Audit done randomly, annual plan is not available, Audit closer is not proper, audit compliance are not reviewed in Management review meeting.

7.  Device History Records and CFR Part 820.184 Incomplete, completed in hurry just before audit, quality and regulatory are not in full control of DHR.

8.  Design Validation and CFR Part 820.30(g) Protocol is not adequate; all aspects of validation are not covered. Documentation is not proper.

9 PMS (post marketing surveillance) System is not followed. Some reportable incidents are not informed to FDA. Some critical or major complaints related to product not covered in PMS

10 UDI (Unique Device Identification) system documentation and records are poorly maintained.

11. Production, process control and quality control and assurance: System inadequate, documentation is not timely, and records are filled late or improper. Critical values are not verified by another independent person.

IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.

[zyrexhealthcare]

Zyrex is based in Pune, India. We are in the Business of Manufacturing, Marketing, Distribution and Exports of Active Pharmaceuticals Ingredients, Finished Formulations & medical devices.

[cheapbricksandpaversinperth]

 Kemwell Biopharma provides customized process, product development & manufacturing solutions to biopharmaceutical organizations worldwide.

For More Info Please Visit :

[nadeem106]

The last decade was ours but the next decade will be even brighter for India-Pankaj Patel

On July 4, Zydus Lifesciences said in a regulatory filing that it has received tentative approval from the US Food and Drug Administration (USFDA) to market generic Azilsartan Medoxomil tablets used to treat high blood pressure. In June, the company and Dr Reddy’s also announced a licensing agreement for co-marketing of Pertuzumab biosimilar, a critical treatment for breast cancer. This was developed in-house by the research team at the Zydus Research Centre (ZRC), and will be marketed by Zydus under the brand name Sigrima and Dr Reddy’s will market it under the brand name Womab.

[lscopepharmainstitute]

Regulatory Affairs Courses in India: A Complete Guide for Aspiring Professionals

The field of Regulatory Affairs is gaining immense popularity as the pharmaceutical, biotechnology, and medical device industries continue to expand globally. With the increasing demand for safe and compliant products, the role of regulatory professionals is becoming more critical than ever.

Regulatory Affairs involves ensuring that companies comply with all the regulations and laws pertaining to their business. In India, this career path is becoming more prominent, and various institutes are offering specialized Regulatory Affairs courses.

Why Choose Regulatory Affairs?

Regulatory Affairs professionals play a vital role in ensuring that pharmaceutical and healthcare products are safe, effective, and of high quality. These professionals are responsible for submitting drug approvals, ensuring compliance with legal and ethical standards, and managing product lifecycle documentation.

Pursuing a career in Regulatory Affairs can lead to roles in:

Drug development and approval processes

Clinical trials management

Compliance with national and international regulations

Regulatory submissions and audits

Labeling and marketing authorization

Post-market surveillance and product lifecycle management

Given the growth in the pharmaceutical and medical device sectors, the demand for regulatory professionals is on the rise.

Top Regulatory Affairs Courses in India

India offers several excellent courses that provide both academic and practical knowledge in Regulatory Affairs. Here are some of the top programs you can consider:

1. Lscope Pharma Institute

Program Offered: Certificate and Diploma Courses in Regulatory Affairs

Overview: Lscope Pharma Institute is one of the leading providers of specialized Regulatory Affairs courses in India. Their programs cover key areas like pharmaceutical regulations, drug development processes, clinical trials, and compliance with international regulatory agencies. These courses are ideal for professionals looking to advance their careers in regulatory affairs within pharmaceutical companies.

Course Link: Lscope Pharma Institute Courses

For a more detailed list of regulatory affairs courses in India, you can visit Lscope Pharma’s dedicated course page, which offers comprehensive information on available programs and career paths.

2. Jamia Hamdard University, New Delhi

Program Offered: M.Pharm in Pharmaceutical Regulatory Affairs

Overview: This program provides in-depth knowledge of regulatory guidelines, with a focus on drug approval processes, clinical research, and global regulatory environments. The curriculum covers both Indian and international regulations, including those of the USFDA, EMA, and CDSCO.

3. National Institute of Pharmaceutical Education and Research (NIPER), Mohali

Program Offered: M.S. in Regulatory Toxicology and Regulatory Affairs

Overview: NIPER offers one of the most comprehensive programs in Regulatory Affairs in India, with a focus on regulatory toxicology, clinical trials, and global regulatory standards. This program is ideal for students looking for advanced education in regulatory affairs with research-based learning.

4. Institute of Clinical Research India (ICRI)

Program Offered: Postgraduate Diploma in Clinical Research and Regulatory Affairs

Overview: ICRI offers a combination of clinical research and regulatory affairs, focusing on compliance, clinical trials, and submission processes for drug approvals. This course is designed to provide both theoretical and practical insights into regulatory affairs.

What You Will Learn in a Regulatory Affairs Course

Whether you choose to pursue a certificate or a degree in Regulatory Affairs, the coursework generally includes:

Regulatory Frameworks: Understanding the regulations governing pharmaceutical products in India and internationally (USFDA, EMA, CDSCO, etc.)

Drug Approval Process: Learning how to navigate the drug development lifecycle, from preclinical trials to post-market surveillance

Clinical Trials: A detailed understanding of clinical trials, ethical guidelines, and the role of regulatory professionals in monitoring trial compliance

Quality Control & Compliance: Ensuring that products meet national and international safety standards and quality guidelines

Global Regulatory Submissions: Preparing and submitting documents required for drug approvals in different regions

These courses provide the necessary foundation to pursue a successful career in the regulatory field, with opportunities to work in pharmaceutical companies, biotech firms, medical device companies, and regulatory bodies.

Career Prospects in Regulatory Affairs

A career in Regulatory Affairs is both challenging and rewarding. With the pharmaceutical industry in India rapidly growing, the demand for regulatory professionals is increasing. Upon completing a Regulatory Affairs course, you can explore various job roles, including:

Regulatory Affairs Executive

Regulatory Affairs Manager

Compliance Officer

Clinical Trials Coordinator

Quality Assurance Specialist

Salaries for regulatory professionals can range from INR 3–6 lakhs annually for entry-level positions, with experienced professionals earning upwards of INR 10 lakhs per annum, depending on the company and location.

Choosing the Right Course

Before enrolling in a Regulatory Affairs course, consider the following:

Curriculum: Make sure the course covers both Indian and international regulatory frameworks, as pharmaceutical companies often target global markets.

Accreditation: Ensure that the institute offering the course is recognized and accredited by regulatory bodies.

Industry-Relevant Learning: Look for courses that include practical training, case studies, or internships, as these are invaluable for real-world regulatory work.

Institutions like Lscope Pharma Institute offer targeted Regulatory Affairs courses that are updated to meet the current industry standards and expectations. For further reading, you can also explore their detailed blog post on What is Regulatory Affairs in Pharma? to better understand the field.

Conclusion

With the increasing complexity of global regulations, the role of regulatory professionals has become indispensable. Pursuing a Regulatory Affairs course in India equips you with the knowledge and skills to navigate these regulations, ensuring that products are compliant, safe, and effective. Whether you aim to work for a multinational pharmaceutical company or in the growing biotech sector, completing a course in regulatory affairs can be your gateway to a rewarding career.

If you’re looking to start or advance your career in Regulatory Affairs, consider enrolling in a specialized program like the one offered by Lscope Pharma Institute, which provides comprehensive courses tailored to the needs of today’s pharmaceutical professionals.

[sudheervanguri]

MOREPEN, a leading pharmaceutical company with a strong global presence and regulatory approvals from WHO, USFDA, EU, and TGA, is hosting a walk-in interview on 15th September (Sunday) at 9 AM onwards in Baddi, Himachal Pradesh. The company’s focus on advanced R&D and new API formulations offers exciting career opportunities for skilled professionals in the pharmaceutical sector. If you are passionate about working in a regulated environment and are experienced in pharmaceutical manufacturing or R&D, this could be your chance to grow with a dynamic and reputed organization. Available Roles and Requirements: 1. Analytical Development Lab (ADL) and Formulation & Development (F&D) Experience: 1-6 years Qualification: M.Sc. (Chemistry), M.Pharma (Pharmaceutics) Candidates with hands-on experience in regulated markets such as USFDA and Europe are preferred. You will be part of a team dedicated to new product development and advanced formulations. 2. Production (Packing) – Officer/Executive Experience: 2-8 years Qualification: B.Pharma / M.Pharma / ITI Responsible for operating bottle machines (primary packaging), ensuring the smooth running of the production line, and maintaining compliance with regulatory standards. 3. Quality Assurance (QA) / Quality Control (QC) Experience: 2-8 years Qualification: B.Pharma / M.Sc. / M.Pharma Join the QA/QC team to oversee quality management systems, testing, and compliance, ensuring the highest standards in our production and formulation processes. 4. Warehouse – Operator/Staff Experience: 4-6 years Qualification: BA / B.Sc. / D-Pharma Warehouse professionals will manage inventory, ensure accurate stock control, and handle pharmaceutical products with strict adherence to safety and quality protocols. 5. Production (Mfg.) – Officer/Executive (Granulation/Compression, Capsule/Coating) Experience: 2-8 years Qualification: B.Pharma / M.Pharma / ITI Manufacturing professionals are required to handle critical processes such as granulation, compression, capsule filling, and coating within a regulatory-compliant environment. 6. Intellectual Property Rights (IPR) Experience: 2-6 years Qualification: M.Pharma The IPR team plays a critical role in protecting MOREPEN’s innovative developments, managing patent filings, and ensuring the company's intellectual property is safeguarded. 7. Pharmaceutical Engineering – Operators (Fitter, Electrician, Water System Operator, OAHU Operator) Experience: 1-4 years Qualification: ITI / Diploma Engineering professionals will manage the installation, operation, and maintenance of equipment in the production units, ensuring smooth and efficient workflows in regulated environments. [caption id="attachment_102148" align="aligncenter" width="930"] Dr. Morepen Career Recruitment - Job vacancies[/caption] Walk-in Interview Details: Date: 15th September 2024 (Sunday) Time: 9 AM onwards Venue: Hotel 4 Seasons, Near Baddi Lights, Baddi, Himachal Pradesh Candidates with experience in pharmaceutical formulations, especially in regulated markets (USFDA & MHRA), are encouraged to attend. How to Apply: If you are unable to attend the walk-in interview, you can still apply by sending your updated resume to: 📧 pushpa.thakur@morepen.com 📧 deepika.vij@morepen.com Please bring the following documents: Updated CV Latest salary slip Passport-sized photograph

[savahealthcare]

Herbal health care products

Established in 2003, SAVA Healthcare is an Indian multinational and one of the fastest-growing pharmaceutical companies. SAVA Healthcare is committed to making Life “Feel Good”.

The company has a WHO-GMP & PIC/s approved manufacturing plant in Gujarat, a herbal extract plant in Bengaluru and a R&D facility in Pune. Furthermore, the company is in the process of deploying an USFDA-accredited plant near Indore in the coming years.

[poonamcmi]

Cyproterone Acetate Market Poised to Grow at a Robust Pace due to Rising Demand for Anti-Androgens

The cyproterone acetate market has witnessed rising demand over the years owing to increasing applications of cyproterone acetate as a powerful anti-androgen. Cyproterone acetate is an anti-androgen steroidal drug that is used for the treatment of hypersexuality or hypersexual disorder, enlarged prostate or benign prostatic hypertrophy, and hirsutism or excessive hair growth in women. It acts by competitively inhibiting androgens like testosterone and dihydrotestosterone from binding to androgen receptors in target tissues.

The Global cyproterone acetate market is estimated to be valued at US$ 327.1 Mn in 2024 and is expected to exhibit a CAGR of 4.5% over the forecast period 2024 to 2031.

Key Takeaways

Key players operating in the cyproterone acetate market are Curia, Axplora, LGM Pharma, Hubei Gedian Humanwell Pharmaceutical, Cipla, NEWCHEM SPA, Swati Spentose, Teva API, Teva Pharmaceutical Industries, Unipex, Zhejiang Xianju Pharmaceutical Co. Ltd, KRKA, Cambrex, Sicor De México, Zhejiang Xianju Xianle, Shaoxing Hantai Pharma, and Farmabios. The key players are engaged in developing improved formulations and delivery methods of cyproterone acetate to increase market share.

The rising prevalence of hormonal disorders like hypersexuality, hirsutism and benign prostatic hyperplasia has opened up opportunities for pharmaceutical manufacturers in the Cyproterone Acetate Market Size Furthermore, increasing awareness about treatment options and availability of generic drugs are fueling the demand.

Technological advancements in drug delivery systems like transdermal patches, gels, and nano-formulations are allowing for better management of hormonal disorders and can drive the adoption of cyproterone acetate.

Market Drivers

A key driver for the cyproterone acetate market is the rising geriatric population who are more prone to benign prostatic hyperplasia. Furthermore, changing lifestyles and increasing stress levels have contributed to the rise in disorders like hypersexuality which is also propelling the demand. Favorable government policies for generic drugs and availability of generic versions of cyproterone acetate at lower costs are facilitating greater market penetration. Challenges in Cyproterone Acetate Market:

Patent Expiry of Acetate Products. Cyproterone Acetate Market  Size And Trends drugs are widely used in the treatment of sex hormone-dependent disorders like precocious puberty, hirsutism and acne, however many patented drugs containing cyproterone acetate are going off patent in the coming years leading to increased competition in the generic market.

Stringent Regulatory Guidelines: Approval processes for new drugs and formulations containing cyproterone acetate are long and stringent. Regulatory authorities like USFDA and EMA impose rigorous evaluation procedures to ensure safety and efficacy. This increases clinical trial timelines and costs.

Potential Side Effects: Cyproterone acetate has few potential side effects if taken for a long duration. Side effects reported include nausea, vomiting, headache, breast tenderness or swelling. Rare side effects include hepatitis, changes in liver function values and blood clotting problems. Potential risks require monitoring and further research on safety.

SWOT Analysis:

Strengths: High growth opportunities in generic drugs market. Well established uses in treatment of hormonal disorders. Weaknesses: Patents expiry of branded drugs. Potential side effects require further safety evaluation. Opportunities: Developing novel drug delivery systems to reduce side effects. Approval of new treatment indications will boost growth. Threats: Stringent regulations delay market approvals. Intense competition from existing and emerging players.

Geographical Regions:

Currently North America accounts for the largest share in cyproterone acetate market, mainly driven by high treatment rates for hormonal disorders. Emergence of new generics and strong reimbursement structure also supports growth. Europe follows North America and holds significant revenue share due to rising healthcare expenditures.

Fastest Growing Region: Asia Pacific region is poised to be the fastest growing market for cyproterone acetate. Increasing patient pool suffering from hormonal imbalance, rising medical tourism, growing healthcare infrastructure and entry of low-cost generics will drive robust growth in Asia Pacific during forecast period. India and China will be the key revenue generators in this region.

Current challenges in Cyproterone Acetate Industry: The cyproterone acetate industry faces challenges from generic competition as major patents expire. Several drugs containing cyproterone acetate as active ingredient lost exclusivity in last few years leading to availability of low-cost generics. This has significantly reduced prices of branded formulations impacting revenues of innovator companies. Another challenge is the stringent regulatory norms for approval of new drugs. The regulatory processes have become complex over time warranting extensive clinical data and trials increasing costs and timelines for industry players. Potential side effects also require further evaluation on long term safety profile through ongoing clinical research. High development costs and regulatory hurdles restrict entry of new market entrants. Overall, generic competition and regulatory challenges are major pain points for cyproterone acetate industry currently. Get More Insights On, Cyproterone Acetate Market For More Insights Discover the Report In language that Resonates with you

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About Author: Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191

[poojapandit]

Right time to Submit USFDA 510(k): Timing Your FDA Application Strategically

Understanding the USFDA 510(k) Submission: A Key to Medical Device Success

Navigating the USFDA 510(k) submission process is crucial for medical device manufacturers aiming to enter the U.S. market. This regulatory step ensures that your device is substantially equivalent to an existing legally marketed device in terms of safety and effectiveness. Proper execution of this process can significantly enhance market success, provide a competitive edge, and ensure patient safety.

Why Timeliness and Accuracy Matter

Timely and accurate 510(k) submissions offer several distinct advantages:

Market Advantage: Submitting your 510(k) early allows you to seize market opportunities and gain a competitive edge. To learn more about the right timing for your submission, visit this guide.

Efficient Review: A well-prepared submission provides the FDA with the necessary information for a thorough review, reducing the likelihood of delays. Ensure your submission aligns with guidelines by checking out our detailed advice.

Swift Approval: Accurate submissions result in quicker approvals, accelerating your device's market entry. For tips on optimizing your submission timing, refer to this resource.

Key Points About the 510(k) Process

The 510(k) process involves demonstrating that your device is similar to an existing, legally marketed device. This submission is primarily required for moderate-risk Class II devices but may also apply to some Class I and Class III devices.

Identifying a suitable predicate device is crucial. Ensure it matches your device in intended use and technological characteristics. If significant modifications or new performance data are involved, a new 510(k) submission is necessary. For further details on submission timing and requirements, visit our guide.

For expert guidance on your 510(k) submission, Operon Strategist offers comprehensive support to streamline the process and ensure regulatory success. Explore our services to learn more.

Need Expert Assistance? Contact Operon Strategist today for expert advice on your 510(k) submission and achieve a successful market entry.

[izielhealthcare]

How to Choose Regulatory Consulting Services?

The top medical device consultants have relevant industry experience have relevant experience within the industry, knowledge of the right regulatory frameworks, and proven experience working on similar projects. Regardless of whether you’re trying to develop a regulatory strategy, prepare for submission or respond to the FDA, working with a consultant who’s succeeded in similar situations can increase your chances of a favorable outcome.

IZiel implements an Outcome-Based Delivery Model to provide a complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA & India collaborate to develop a Cost-Effective Model to complete USFDA Approvals for customers in USA, Europe and Asia.

Upon completion of Engineering & QMS Documentation, the regulatory team of IZiel conducts the predicate device search, comparative analysis and ensure all the necessary standards are complied with. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants. Our highly experienced US regulatory consultants include Ex-FDA Auditors, have conducted 3500 + reviews and approvals and have experience with Class I, II & III devices in Cardiology, Neurology, Image Diagnostics and Orthopedic products.

[zyrexhealthcare]

We are Exporter, Supplier and Manufacturer of Pharmaceutical Branded and Generic Finished Formulations in Pune, India. We strictly follow all quality standards and accept Private Labelling Contracts manufacturing for Pharma finished formulations as per client requirement. Since 2003 and manufacturing API drugs, Orphan Drugs and Hospital Care Products are available. Get best price medicine available in our website.

[cheapbricksandpaversinperth]

Top Pharmaceutical CDMO

Top Pharmaceutical CDMO

Who we Are

                            This is the Asia’s best & India’s largest Biologics CDMO with integrated development and manufacturing capabilities

                           Kemwell is a biologics contract development and manufacturing organization(CDMO).This is providing services to global pharmaceutical and biotech organizations.Our facilitiesare designed and developed with technological support.And from a leading German biopharmaceutical company.

About Us

Why Kemwell

INTEGRATED SERVICE PROVIDER

Drug Substance and Drug Product from same site

DIVERSE EXPERIENCE

Monoclonal antibodies,complex fusion proteins,recombinant proteins and bispecific anibodies

FIRST BIOLOGICS CDMO IN INDIA

Licensed to manufactur ecommercial DS

HYBRID TECHNOLOGY BIOMANUFACTURING

SS and SUBwith flexibility of scale.

Process Development Companies USA

WHAT WE DO

Our Services

Kemwell provides integrated development and manufacturing services for companies that require a one-stop solution for mammalian cell-culture based proteins therapeutics-monoclonal antibody,bi-specific or multi specific antibodies,fusion proteins, etc.

Biologics Development

                                              The team is experienced to undertake a end-to-end activities right from cell line development till cGMP clinical and commercial manufacturing.Kemwell also undertakes standalone projects such as process optimization,analytical method development or validation,formulation development and optimization,stability studies,resin reuse study,tech transfer and cGMP manufacturing,process characterization, etc.

For More Info Please Visit :

https://www.kemwellbiopharma.com/

[sa7abnews]

FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD

New Post has been published on https://sa7ab.info/2024/08/16/fda-rejects-mdma-as-psychedelic-based-treatment-for-mental-health-ptsd/

FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD

The U.S. Food and Drug Administration (FDA) announced Friday its rejection of MDMA as a treatment for PTSD.The decision was based on “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication,” the FDA stated, according to The Associated Press.MDMA, also known as ecstasy or molly, is a psychedelic drug with effects that are similar to methamphetamine, according to the National Institute on Drug Abuse.FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANSVeteran organizations have long been advocating for approval of psychedelic-assisted therapies to treat mental health challenges.The FDA’s decision comes nearly eight weeks after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD.The FDA has requested another Phase 3 trial to confirm the drug’s safety and efficacy.Lykos Therapeutics, the California company that filed the drug application, said it plans to meet with the FDA to appeal the decision, according to reports. MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL”The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Amy Emerson, the Lykos CEO, said in a statement from the company.”While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”An FDA spokesperson released a statement regarding the decision.”As discussed at the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.” Regarding the need for additional treatments for PTSD and other mental health conditions, the agency said it encourages further research and development to “further innovation for psychedelic treatments and other therapies to address these medical needs.”PharmAla Biotech, a Toronto-based company focused on researching, developing and manufacturing novel derivatives of MDMA, reacted to the decision in a statement sent to Fox News Digital.”USFDA has an important responsibility to get things right, and we believe that they are acting in good faith. However, there is a vitally important patient need for novel PTSD treatments, which must be balanced with that prudency,” said Nicholas Kadysh, CEO of PharmAla Biotech. “MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient treatments in two jurisdictions, Canada and Australia, entirely supplied by PharmAla.”Kadysh added that the company is committed to ongoing research to “convince even the most skeptical regulators that this medicine is both safe and effective.”CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER Joe Perekupka, CEO of Freespira, the Washington-based company that makes an FDA-approved digital therapeutic for PTSD and anxiety, also reacted to the decision.”The FDA’s recent decision on MDMA underscores the complex landscape of mental health treatments. At Freespira, we recognize the urgent need for additional effective PTSD treatments, but support the FDA’s commitment to patient safety when reviewing potential new treatments,” he said in a statement to Fox News Digital.For more Health articles, visit www.foxnews/health”We believe in the importance of diverse treatment options and will continue to focus on our mission of democratizing access to advanced mental health care through our patient-centric model.”Fox News Digital reached out to the FDA and to Lykos Therapeutics requesting comment.

[healtharkinsightss]

Healthcare Innovation Podcast Episode 16 with Rahul Rastogi, CEO, Agatsa

In this episode, Rahul Rastogi, CEO of Agatsa, details his journey of building the world's smallest 12- Lead ECG device. This podcast will throw light on the journey of an innovative company through its R&D, clinical, and commercial phases. We are sure this podcast would provide insights on the regulatory landscape, particularly with regard to the USFDA approvals for companies trying to get certified.