Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 81

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Guidances: This site contains FDA’ s new, current, revised, and withdrawn guidance in all areas, including Drug Safety, ICH, OTCs, Good Review Practices, the FDAAA Food and Drug Administration Amendments Act (2007), the FDA Safety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.

Pregnancy and Lactation Labeling.

Prescription Drug User Fee Act (PDUFA): The main web page for information on PDUFA, including the current version, with several links.

Office of Surveillance and Epidemiology (OSE).

Guidance, Compliance, and Regulatory Information: This page has links to the various laws, acts, guidance, and so forth.

Surveillance: Post-drug Approval Activities: Links to the staff guide, regulations and policies, advertising, and promotional information.

FDA Adverse Event Reporting System (FAERS): This site has the description of the main FDA drug safety database, with post-marketing data files and statistics for chemical drugs and therapeutic biologics, including data migrated from predecessor databases. There is a fairly user-friendly “Public Dashboard” that supports navigation of redacted FAERS data (additional details at www.fda.gov).

Vaccine Adverse Events Reporting System (VAERS): This site contains post-marketing reports for vaccines regulated by CBER. The database is housed by a vendor and scientific access is shared by CBER and the Centers for Disease Control.

Electronic Medical Device Reporting (eMDR) System: This site has post-marketing safety (“incident”) data for medical devices regulated by Center for Devices and Radiologic Health (CDRH) and reported by manufacturers and user facilities.

MedWatch to Manufacturer Program: The system whereby FDA informs applicants of SAEs that are received directly by FDA for the first 3 years after a new product is marketed. This is activated only on request of the applicant (see “MedWatch” below). Note: The MHRA in the United Kingdom has a similar program.

DailyMed: This is actually an NIH website that provides “high quality information about marketed drugs”. It is not a complete listing but does have information on more than 7,000 drugs. See the Drugs@FDA site.

Medication Guides.

Medication Errors.

Safe Use Initiative: FDA’s program to reduce preventable harm from medications. This FDA website is extensive, and almost everything that one wants to find relating to the FDA, drugs, and drug safety are present, though often not easy to find. In addition, FDA changes its websites frequently, and pages may jump or be moved, or URLs may be dead links. It may be necessary to search for the new URL using the FDA search engine on the home page. Note that most, but not all, of the drug safety information is in the CDER section of the website.