Regulations and Policies and Procedures for Postmarketing Surveillance Programs
The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.
Code of Federal Regulations (CFR)
The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes. Section 21 of the CFR contains all regulations pertaining to food and drugs. The regulations document most actions of new drug sponsors that are required under Federal law. The following regulations apply to adverse drug event reporting.
|21CFR310.305||Records and reports concerning adverse drug experiences of marketed prescription drugs for human use without approved new drug applications|
|21CFR312.32||Investigational New Drug Safety Reports|
|21CFR314.80||Postmarketing reporting of adverse drug experiences|
Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.
- Drug Safety Guidances
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95KB). (Issued 8/27/1997, Posted 8/27/1997)
CDER's Manual of Policies and Procedures (MaPPs) provide official instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities. MaPPs define external activities as well. All MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures.
- 6004.1. Granting Waivers Under 21 CFR 314.90 for Postmarketing Safety Reporting Requirements Under 21 CFR 314.80 (11/16/1999, Posted 11/17/1999)
6010.1. NDAs: Preapproval Safety Conferences. Provides for communication between the Office of Drug Evaluation review divisions and the Office of Post-Marketing Drug Risk Assessment (OPDRA) risk evaluation divisions ensuring that OPDRA is aware of potential postmarketing safety problems in drugs about to be approved. (Issued 11/15/1999, Posted 11/17/1999)
4731.0. Drug Shortage Management. Provides an overview of CDER's drug shortage management responsibilites, and how drug shortage reports are processed.