broadcasts produced by FDA on Facebook, Twitter, etc.
Another little-known MedWatch function is the MedWatch to Manufacturer Program (see above), which allows drug and biologics manufacturers to receive certain serious AEs submitted directly to FDA that would not otherwise be known to the manufacturer. An applicant can subscribe at any time within 3 years after product approval; FDA will send reports for a period of about 3 years after approval.
The other key part of the MedWatch site is information on reporting serious AEs to the FDA using the MedWatch form, which comes in three very similar variations — the 3500-form for the public to voluntarily submit AEs, the 3500B-form that is more consumer-friendly than the 3500-form, and the 3500A-form for mandatory reporting. Manufacturers usually use the 3500A-form only for expedited reporting from clinical trials; structured electronic reporting is required for marketed products.
An information page for health professionals and the public describes the systems used for safety reporting, which then has links to the other pages giving further information. There are links to downloadable PDF versions of the MedWatch forms. There is also a link to an online reporting form for the public.
There is a page with information for industry on the three key serious AE reporting areas. Information and links to the appropriate regulations and forms are included:
OTC Products and Dietary Supplements;
Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers;
Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting.
Safety Databases
The FDA maintains several databases that contain safety information:
FDA Adverse Event Reporting System (FAERS): This is a computerized information system for FDA’ s post-marketing safety surveillance program for drugs and biologics. It is compliant with the data elements specified in the ICH E2B guideline. This database is one of the largest of its kind and contained over 15-million ICSRs as of mid-2018. More than half of these are classified as serious. Quarterly (non-cumulative) data files since January 2004 are available for downloading as zipped SGML or ASCII files. The data in these files are not cumulative and not searchable online. However, there is a “Public Dashboard” that supports searches of FAERS data. It is also possible to request FAERS cases (redacted) using Freedom of Information (FOI) requests.
Data freely available for querying via the “Public Dashboard” include patient demographics, the suspect drug(s) reported, the adverse reaction(s), patient outcome, and the source of the reports. It is possible to stratify and organize data by product, patient age, type of adverse event, the timeframe in which the event occurred, etc.
Post-marketing Requirements (PMRs) and Commitments (PMCs): This database contains information on studies and trials that applicants have committed to carrying out after drug approval.
Vaccine Adverse Event Reporting System (VAERS): VAERS is a cooperative database run by the CDC and the FDA. VAERS collects information about AEs that occur after the use of licensed vaccines, or adverse events following immunization (AEFI). See below under CBER.
Manufacturer and User Facility Device Experience Database (MAUDE): This database contains selected safety information for medical device reports since 1991 and is updated weekly. See below under CDRH.
Clinical Trials Database: This is not a safety database but has information about governmental and private clinical trials under way in the United States and globally. There are tens of thousands of trials in more than 170 countries on file. Some contain safety information. The PDUFA/FDAAA laws require safety information to be put online and this has been a gradual process. See: www.clinicaltrials.gov
Other databases include such topics as poisonous plants.
Other Useful FDA Web Pages
Post-market Drug Safety Information for Patients and Providers: A one-stop shopping page for just about everything you want to know about safety.
FDA guidance for FDA-regulated products.
Office of Non-prescription Drugs (OTCs).
Potential Signals of Serious Risks New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS).
Prescription Drug User Fee Acts (PDUFA), which are on 5-year cycles. PDUFA legislation specifies deadlines for the FDA to review new drug applications (normally 10-months for new drugs or 6-months for priority review, beginning on the date that FDA accepts the application).
Food and Drug Administration Amendments Act (FDAAA) of 2007.
Warning Letters.
Summaries of approved Risk Evaluation and Mitigation Strategies (REMS).
Global Health Agencies (links).
Dietary Supplements.
Code of Federal Regulations.
Drugs@FDA — the US labeling for most approved drugs.
Finally, there is a very useful page that covers mandatory post-marketing reporting by drug and biologic manufacturers, distributors, and packers. There are hyperlinks to the applicable federal regulations:
Labeling
201.56 — Requirements on content and format of labeling for human prescription drug and biological product
Other
