Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 85

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 labeling regulations

208 — Medication Guides for Prescription Drug Products

310.501 — Patient package inserts for oral contraceptives

310.515 — Patient package inserts for estrogens

312 — Investigational New Drug (IND) Application

312.32 — IND safety reports

312.33 — Annual reports

312.88 — Safeguards for patient safety

314 — Applications for FDA Approval to market a New Drug (NDAs)

314.80 — Post-marketing reporting of adverse drug experiences

314.81 — Other post-marketing reports

314.97 — Supplements and other changes to an approved abbreviated application (ANDA)

314.98 — Post-marketing reports

314.520 — Approval with restrictions to assure safety use

314.540 — Post-marketing safety reporting

314.630 — Post-marketing safety reporting

601 — Biological Licenses

601.12 — Changes to an approved application

601.32 — General factors relevant to safety and effectiveness

601.35 — Evaluation of safety

601.93 — Post-marketing safety reporting

610 — General Biological Products Standards

610.11 — General safety

In addition, other key documents such as FDA instructions for field staff, E2B ICSR submission information, ICH documents, and others are available.