communication of drug safety information to healthcare professionals, patients, and the general public;
Establishment of general policies regarding drug safety issues and approaches to resolving internal FDA policy differences and disagreements; and
Disputes between a sponsor and CDER concerning Risk Evaluation and Mitigation Strategies (REMS) that occur after approval of a prescription product, if the sponsor requests DSB review.
FDA’ s SOP for the board is available (www.fda.gov). In fact, almost all of FDA’s policies and procedures are available on their website. The FDA has an extensive, useful website, although the information tends to be scattered and difficult to find. There is a search engine that is somewhat useful. The website has extensive information on how the FDA works, its history, drug availability, counterfeits, Internet purchases of drugs, labeling and medication guides for drugs on the market, signals, REMS, guidance, laws and regulations covering pharmaceuticals (as well as devices, biologics, radio-logic agents, over-the-counter (OTC) products, nutraceuticals, and more). The main CDER website lists late news and provides a jumping off point to other CDER information, including:
FDA Basics: This provides fundamental information on the various divisions, functions, and leaders at FDA.
Drug-Specific Information: This is an alphabetical list of drugs that have an information sheet, Early Communication about an Ongoing Safety Review, or other important information.
Development and Approval Process for Drugs: This provides information on how drugs are developed and approved.
Guidance, Compliance, and Regulatory Information: For industry, this key page for pharmacovigilance (PV) professionals has links to information on laws, acts, rules, good review practices, enforcement activities, surveillance, post-marketing commitments requirements, warning letters, enforcement actions, new guidance documents, cyber letters, and the CDER manual of policies and procedures.
Information for Industry: This is a page for the pharmaceutical industry with links to guidance, post-marketing information, the Prescription Drug User Fee Act (PDUFA, which is renewed every 5 years), industry fees, warning letters, electronic submissions, the Orange Book (approved drug products with therapeutic equivalence evaluations), abbreviations, and types of applications.
JumpStart: This is a tool for FDA reviewers to gain insights on data fitness in an application and which analytical tools might be appropriate for use in the review. This was spawned by CDER’s 21st Century Review Process, which is an integrated review process that partitions work into IT functions and scientific analysis. JumpStart is intended to be applied to electronic data between submission of a marketing application by industry and filing of the application by CDER.
MedWatch: See below for more detailed information.
Drugs at FDA: This is a link to the page that has an alphabetical list and search engine to find approved drugs by name, active ingredient, or application number.
openFDA: This is a software tool designed to facilitate public access and use of public FDA data.
Recalls, Market Withdrawals and Safety Alerts.
The Safety Reporting Portal
FDA has launched a “one-stop shopping” safety portal in which electronic case safety reports for nearly all products regulated by FDA (and NIH) can be submitted. Food (human or animal), drugs, biologics, blood products, gene-transfer research issues, and more can be reported by sponsors/applicants/manufacturers/distributors, healthcare professionals, researchers, public health officials, and “concerned citizens”. The features and functionalities of this portal evolve as experience is gained. It allows for initial and follow-up reports. One can enter a case as a “guest” or one can establish an account and use it repeatedly. It is not meant for emergency reporting when a company’s safety system is down. See the Safety Reporting Portal FAQ page. Other pages of interest include the following:
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): This page contains information about ongoing signals. Along the same lines, the 2007 legislation generally required FDA to perform extensive safety analyses of new drugs at 18-months following approval or after 10,000 individuals had been exposed to the drug, whichever was later. However, the 21st Century Cures Act abolished this requirement because a study showed that these assessments had little value. Results were largely the same as those from established safety surveillance practices and they did not reveal important safety issues any sooner. These activities were not a good use of FDA resources so they were curtailed by the 2016 legislation.
Post-market Drug Safety Information for Patients and Providers: This site contains information on post-market study requirements and commitments, a link to the clinical trials registry, and other safety-related information.
Approved Risk Evaluation and Mitigation Strategies (REMS): This site contains summary information and links to REMS summaries that are in place and dates of modifications or release. There is a separate link to a repository of released (previously approved, but inactive) REMS.
Guidances: This site contains FDA’ s new, current, revised, and withdrawn guidance in all areas, including Drug Safety, ICH, OTCs, Good Review Practices, the FDAAA Food and Drug Administration Amendments Act (2007), the FDA Safety and Innovation Act (2012), the 21st Century Cures Act (2016), and the FDA Reauthorization Act of 2017.
Post-market Drug Safety Information for Patients and Providers: Selected Safety Regulations: This page has links to the relevant sections of the Code of Federal Regulations covering safety matters for drugs and biologics, as well as INDs, NDAs, BLAs, STNs (submission tracking numbers), and labeling.
Warning Letters: A site with many years of warning and untitled letters for all matters, not just safety, that are searchable by company (or investigator, etc.), issuing office, and so forth.
