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Fda Periodic Safety Update Reports

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The US is alone in requiring two different types of reports, referred to as the NDA (New Drug Application) safety update (“quarter- ly”) and the annual (“periodic”) reports, both covering clinical experience; however, the latter does not focus on detailed safety data. The Periodic Safety Update Report (PSUR) is a document summarising the results and conclusions of the analysis of Post-Market Surveillance (PMS) data with usage data. The purpose of the PSUR is to track the conclusions of the benefit-risk determination, the main findings of the Post-Market Clinical Follow-Up (PMCF) and the volume of sales throughout the lifetime of the device concerned. The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety si. This guidance is intended to assist applicants and other responsible parties in fulfilling the FDA=s existing postmarketing safety reporting requirements for human marketed drug and biological.

Periodic Adverse Drug Experience Reports (PADERS): NDA Periodic Reports and Periodic Safety Update Reports (PSURs)

Most countries now accept and usually require the submission of Periodic Safety Reports for aggregate postmarketing safety reporting. The U.S. Food and Drug Administration (FDA) accepts PSURs, though this must be agreed on with the agency in writing beforehand. The older format, NDA Periodic Reports, also called Periodic Adverse Drug Experience Reports (PADERs), are still required according to the regulations (unless there is the PSUR waiver), though FDA will likely require PSURs in the near future.

In addition to the 15-day alert reports, the FDA requires the submission of New Drug Application (NDA), Abbreviated NDA, and Biologic License Application (BLA) periodic reports. The regulations covering this are found in 21CFR314.80(c)(2)(I, II).

As with Investigational New Drug application (IND) regulations, there are updates scattered in various other FDA documents. Some are arguably specific to premarketing settings (e.g., drug-induced liver injury) but should be kept in mind with postmarketing aggregate reporting too:

Postmarketing Reporting of Adverse Drug Experiences (March 1992)

Guideline for Adverse Experience Reporting for Licensed Biological Products (October 1993)

Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (August 27, 1997)

Post-marketing Safety Reporting for Human Drugs and Biological Products Including Vaccines (March 2001)

Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (February 2005)

Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009)

Drug Safety Information—FDA’s Communication to the Public (March 2007)

Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (March 2009)

Postmarketing Studies and Clinical Trials—Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (July 2009)

Enforcement of the Postmarketing Adverse Drug Reporting Regulation. Staff Manual Guide: Chapter 53; Postmarketing Surveillance and Epidemiology: Human Drugs. Adverse Drug Effects

See FDA’s guidance pages (Web Resource 17-1).

The basic regulations state the following (21CFR314.80(c)(2)(I, II)):

All “adverse drug experiences” not submitted as 15-day alert reports must be submitted in the periodic report. A periodic report for each NDA must be submitted quarterly (every 3 months) for the first 3 years after the approval of the NDA. After the 3-year period is over, the reporting frequency is then yearly unless the FDA requests otherwise.

Each report must be submitted 30 days after the close of the quarter for quarterly reports and 60 days after the close of the anniversary date for yearly reports. Thus, the company has 30 or 60 days to prepare the report. The FDA may alter this schedule if they wish to continue quarterly reporting after the 3-year period is over.

Each periodic report is required to contain the following:

A narrative summary and analysis of the information in the report and an analysis of the 15-day alert reports submitted during the reporting interval (all 15-day alert reports must appropriately reference the applicant’s patient identification number, adverse reaction term(s), and date of submission to the FDA).

A MedWatch form (3500A) for each adverse drug experience not reported as a 15-day expedited report (with an index consisting of a line listing of the applicant’s patient identification number and adverse reaction term(s)).

A history of actions taken since the last report because of adverse drug experiences (e.g., labeling changes or studies initiated).

Periodic reporting, except for information regarding 15-day alert reports, does not apply to adverse drug experience information obtained from postmarketing studies (whether or not they were conducted under an investigational New Drug Application), from reports in the scientific literature, or from foreign marketing experience.

Follow-up information to adverse drug experiences submitted in a periodic report may be submitted in the next periodic report.

In August 1997, the FDA published a guidance encouraging NDA holders to submit requests to waive the requirements to submit MedWatch forms for nonserious labeled AEs (Web Resource 17-2).

The March 2001 Guidance at Web Resource 17-3 explains the requirements for a periodic report and is officially in effect even though it remains a draft a decade after being published. It is summarized below.

PSURs to the FDA

The March 2001 Guidance describes the mechanism to obtain a waiver to submit PSURs using the ICH E2C requirements (see Chapter 37) instead of NDA Periodic Reports:

If all dosage forms and formulations for the active substance, as well as indications, are combined in one PSUR, this information should be separated into specific sections of the report when such separation is appropriate to portray accurately the safety profile of the specific dosage forms. For example, one should not combine information from ophthalmic drop dosage forms and solid oral dosage forms.

Copies of the FDA Form 3500A or VAERS form that are required by the regulations must be included. These forms should be included with the PSUR as an appendix. You can request a waiver for submitting certain nonserious, expected adverse experiences on an FDA Form 3500A.

A summary tabulation should be included as an appendix listing all spontaneously reported U.S. individual case safety reports from consumers if such cases are not already included in the PSUR. Summary tabulations should be presented by body system of all adverse experience terms and counts of occurrences and should be segregated by type (i.e., serious/unexpected; serious/expected; nonserious/unexpected; and nonserious/expected).

A narrative should be included as an appendix that references the changes, if any, to the approved U.S. labeling for the dosage forms covered by the PSUR based on new information in the PSUR. A copy of the most recently approved U.S. labeling for the product(s) covered by the PSUR should be included.

Submission Date and Frequency for PSUR Reports. Applicants can request a waiver to submit PSURs to the FDA based on the month and day of the international birth date of the product instead of the month and day of the anniversary date of U.S. approval of the product. The waiver request should specify that these PSURs would be submitted to the FDA within 60 calendar days of the data lock point (i.e., month and day of the international birth date of the product or any other day agreed on by the applicant and the FDA). Applicants can also request a waiver to submit PSURs to the FDA at a frequency other than those required by regulation.

The information contained within a classic NDA Periodic Report should be divided into four sections in the order described below and should be clearly separated by an identifying tab. If information for one of these sections is not included, the applicant should explain why the information is not provided.

Section 1: Narrative Summary and Analysis

A narrative summary and analysis of the information in the postmarketing periodic report and an analysis of the 15-day reports (i.e., serious, unexpected, adverse experiences) submitted during the reporting period must be provided and should include the following:

The number of non-15-day initial adverse experience reports and the number of non-15-day followup reports contained in this periodic report and the time period covered by the periodic report.

A line listing of the 15-day reports submitted during the reporting period. This line listing should include the manufacturer report number, adverse experience term(s), and the date the 15-day report was sent to the FDA.

A summary tabulation by body system (e.g., cardiovascular, central nervous system, endocrine, renal) of all adverse experience terms and counts of occurrences submitted during the reporting period. The information should be taken from

15-day reports submitted to the FDA

Non-15-day reports submitted in the periodic report

Reports forwarded to the applicant by the FDA

Any nonserious, expected, adverse experiences not submitted to the FDA but maintained on file by the applicant

For the adverse experience term “product interaction,” the interacting products should be identified in the tabulation.

A summary listing of the adverse experience reports in which the drug or biologic product was listed as one of the suspect products but the report was filed to another NDA, Abbreviated NDA, or BLA held by the applicant.

A narrative discussion of the clinical significance of the 15-day reports submitted during the reporting period and of any increased reporting frequency of serious, expected, adverse experiences when, in the judgment of the applicant, it is believed the data reflect a clinically meaningful change in adverse experience occurrence.

This narrative should assess clinical significance by type of adverse experience, body system, and overall product safety, relating the new information received during this reporting period to what was already known about the product.

The narrative should also state what further actions, if any, the applicant plans to undertake based on the information gained during the reporting period and include the time period for completing the actions (i.e., when the applicant plans to start and finish the action and submit the information to the agency).

The narrative discussion should indicate, based on the information learned during the reporting period, whether the applicant believes either that (1) no change in the product’s current approved labeling is warranted or (2) there are safety-related issues that need to be addressed in the approved product labeling. If the FDA is considering changes in the approved product labeling, the applicant should state in the narrative the date and number of the supplemental application submitted to address the labeling changes.

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The periodical reporting of aggregate safety reports to regulatory health authorities includes a comprehensive overview of the safety profile of medicinal product based on cumulative safety information accumulated by Marketing Authorization Holder (MAH). They also provide assurance that the MAH is continuously monitoring and critically assessing the benefit-risk profile of the product and taking appropriate risk minimizing actions where new safety concerns or changes to existing safety issues are identified. The international standard for periodic reports follows reporting guidelines set by the International Conference on Harmonization (ICH) (1).

In addition to submission of Individual case safety reports (ICSRs), MAH is obliged to report the cumulative safety exposure data in periodical intervals to respective health authorities within the specified timelines which in turn depends on age of medicinal product in the market and type of aggregate report. This continued monitoring on aggregate safety data facilitates regulators and MAH to maintain positive benefit risk balance and implementing the early risk minimization plans for safety concerns reported.

Based on marketing authorisation status, different types of reports are prepared by MAH, which include the pre-approval aggregate safety reports and post-approval aggregate safety reports.

Pre-approval aggregate reports: It includes the cumulative summary of safety information for molecules under clinical development. It usually includes safety information from non-clinical studies and safety data for the subjects participated in clinical trial.

Annual safety reports (ASRs) in Europe

IND annual reports in United States

However, these two documents were replaced by a well harmonized document, development safety update report (DSUR), in which health regulators in the three ICH regions can receive the same information at the same time, thereby reducing the total number of reports generated.

2. Post-approval aggregate reports: They provide the cumulative summary of safety information for the medicinal products from the marketing exposure. The sources of safety data include Non-clinical, clinical studies and Non international studies, literature articles and spontaneous cases.

The following types of reports are submitted for medicinal products post marketing authorisation.

PADER (Periodic adverse drug experience report)

Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic safety update report (PSUR)

Addendum to clinical overviews (ACO)

Risk management plan (RMP)

Timelines and Regulatory requirements:

DSUR: Marketing authorisation holders are obliged to report the evolving safety profile of investigational medicinal product and actions taken or proposed for the new safety concerns identified during the development to the respective health authority and local regulatory bodies (eg., Institutional review board and local ethics committee). The significant safety findings, serious adverse reactions in line listings, and significant safety information of investigational product and of drugs of similar therapeutic class from published literature are included in corresponding sections of DSUR.

It should be submitted no later than 60 calendar days from the DSUR data lock point (DLP) (2). The DLP for DSUR is stop date of reporting interval for a molecule from the date of authorisation for conducting a clinical trial which is called as developmental International birth date (DIBD).

In addition to the innovator molecules, DSURs are submitted for the marketed products also, which are in clinical trial for other unapproved therapeutic use, comparability studies and for marketed drugs with approved indication which required additional safety monitoring.

PBRER/PSUR: The Benefit-risk evaluation should be carried out throughout the lifecycle of the medicinal product to promote and protect public health and to enhance patient safety through effective risk minimization plans and implementations. After a marketing authorization is granted, it is necessary to continue evaluating the benefits and risks of medicinal products in actual use and/or long term use, to confirm that the benefit-risk profile remains favorable (3)

The date when sponsor received authorisation for marketing a drug is considered as International birth date (IBD) of the medicinal product. Data lock point is the cut-off date for completion of reporting interval. PBRER is a complex report with 20 sections including appendices compared to DSUR and PADER. The timeline for these post approval aggregate reports varies based on the age of medicinal product in the market which included the following kinds of reporting intervals and their respective regulatory timelines.

Table: 1 Timeline for PBRER/PSUR

The comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisation, together with the corresponding EU reference dates, frequencies for submission of periodic safety update reports and related data lock points could be obtained from the European Union reference dates (EURD) list. European Medicines Agency (EMA) updates the EURD list on monthly basis. (4)

A brief overview of primary author responsibilities in preparation of PBRER is depicted here.

A kick off meeting schedule with multiple stakeholders for contributing information into various sections of report. (Regulatory, clinical, finance/sales, medical and signal management teams)

Discussing action items with respective due timelines

Retrieval/reconciliation of line listings (ICSR cases from safety database)

Compilation of safety information received from different stakeholders into a draft PBRER report.

Internal quality & medial review

Amendments of draft report, if required per reviewer comments

Approval of final report

Submission of PBRER to regulatory authority (70th or 90th calendar day)

MAH can get relief in submitting PBRER/PSUR for the products which are well established, generic products in the market for longer time, homeopathic medicines and for traditional herbal medicines.

PADER: Periodic Adverse Drug experience report is a post-marketing safety report submitted to the United States Food and Drug Administration (USFDA). The main objective is to provide summary data with an assessment of an approved drug product’s benefit risk profile from the post marketing exposure. The scope of PADER is limited to serious and unlisted cases which include concise narratives and summary analysis of 15-day ICSR reports. It also includes the regulatory actions taken for safety reasons during the reporting interval since last submitted PADER (5). The US FDA timeline for submission of PADER is presented in the table-2.

Table: 2- Timeline for PADER submissions

ACO: Addendum to clinical overviews are aggregate safety reports which are submitted to respective regulatory authorities for renewal of marketing authorization license of a medicinal product. They include the benefit-risk balance of the medicinal product based on the clinical data. The structure and specifications of the ACO and PBRER are similar. Deep freeze standard 8.38 keygen. But the information presented with greater emphasis on the data received since the last renewal/approval rather than discussing cumulatively. In addition, the history of Pharmacovigilance system inspections (date, inspecting authority, site inspected, type of inspection and if the inspection is product specific, the list of products concerned) with the details of findings and its impact if any on the benefit-risk profile of the product has to be included in the document (6) (7).

Timeline: The MAH should submit the renewal application by the recommended submission dates published on the EMA website (8) and, in any case, no later than 9 months before the marketing authorisation ceases to be valid.

Risk Management Plan(RMP): The main objective of RMP is to document the risk management system considered necessary to identify, characterize and minimize a medicinal product’s important risks. The three major sections of this document include the following (9)

Safety specification: It describes the significant information on important identified and important potential risks and missing information and also on safety concerns which are need to be managed proactively.

Pharmacovigilance Plan: It provides the planning of pharmacovigilance activities to characterize and quantify clinically relevant risks and to identify new adverse reactions.

Risk minimization plan: It includes the planning and implementation of risk minimization measures (RMM), including the evaluation of the effectiveness of RMM activities.

MAH is responsible to maintain a proper risk management system and to monitor continuous influx of safety data from multiple sources for the identification of any new risks and changes to the risk benefit balance of the product. In general, RMP is warranted to prepare with the first 5-year renewal and in the time period when the first PSUR following the first 5 year renewal is due for submission, to review the list of safety concerns and the planned and ongoing Pharmacovigilance and risk minimization activities.

Periodic Report Definition

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Periodic Safety Update Report Example

ICH Efficacy Guidelines, available at https://www.ich.org/page/efficacy-guidelines

Report U. Guidance for Industry Update Report Guidance for Industry E2F Development Safety Update Report. Clin Trials. 2011;(August).

Periodic Benefit-Risk Evaluation Report: ICH (Internet). (cited 2019 Jun 26). Available from: https://www.ich.org/products/guidelines/efficacy/efficacysingle/article/periodic-benefit-risk-evaluation-report.html

European Medicines Agency EURD List, available at https://www.ema.europa.eu/en/glossary/eurd-list

Food and Drug Administration (FDA). Reporting of Adverse Experiences, Code of Federal Regulations, 21CFR314.80, 2016. Available at https://www.gpo. gov/fdsys/granule/CFR-2011-title21-vol5/CFR- 2011-title21-vol5-sec314-80. Accessed on 06 December 2016.

Committee for Human Medicinal Products (CHMP). Guideline on the processing of renewals in the centralized procedure, 2016. Available at http://www.ema.europa.eu/docs/en_GB/document_l library/Regulatory_and_procedural_guideline/2016/0 8/WC500211495. Accessed on 24 November 2016.

The Heads of Medicines Agencies (HMA). Human Medicines: CMDh best practice guide on the processing of renewals in the mutual recognition and decentralised procedures, 2015. Available at http://www.hma.eu/95.html. Accessed on 24 November 2016.

Guideline on the processing of renewals in the centralised procedure, Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-processing-renewals-centralised-procedure_en-0.pdf

GVP Module V – Risk management systems (Rev 2), Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf

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Cons

No Support for Windows XP

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Home > Documents > Word > Where is WordArt in Word 2007, 2010, 2013, 2016, 2019 and 365

Where is the WordArt in Microsoft Word 2007, 2010, 2013, 2016, 2019 and 365

Classic Menu for Office combines the old menus and toolbars of Word 2003 with Ribbon in Microsoft Word 2007, 2010, 2013, 2016, 2019 and 365. It is easy to switch two kinds of user interfaces. It is not necessary to spend extra money and time on learning the Ribbons.

How to Bring Back Classic Menus and Toolbars to Office 2007, 2010, 2013, 2016 and 365? Just Download Classic Menu for Office 2007 or Classic Menu for Office Kutools for Word: 100 Powerful New Features for Word. Office Tab: Tabbed Editing and Browsing in Office, Just Like Chrome, Firefox, IE 8/9/10.

Method A: WordArt in Insert Menu with Classic Menu for Office

You can follow the completely same procedure to access the WordArt command in Microsoft Word 2007, 2010, 2013, 2016, 2019 and 365 as that you did in Word 2003:

Click the Menus tab;

Click the Insert;

Then move your mouse over the Illustrations command item;

Now you will view the WordArt in the sub-menu. See screen shot (Figure 1):

Figure 1: WordArt command in Classic Menu

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Method B: WordArt in Insert Tab if you do not have Classic Menu for Office

If you have not installed Classic Menu for Office on your computer, you can access the WordArt command in Ribbon with following steps:

Click the Insert Tab;

Go to Text group;

Then you will see the WordArt button. See screen shot (Figure 2):

Figure 2: WordArt button in Ribbon