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 all actions of all drug sponsors that are required under Federal law.
Pn544 User Manual Is Only Available Under Nda List
- 21CFR Part 314 - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug.
CDER's Manual of Policies and Procedures (MaPPs)
Prescription Drug User Fee Act (PDUFA)
On November 21, 1997, The President signed the Food and Drug Administration Modernization Act of 1997. This legislation includes authorization for FDA to continue to collect three types of user fees from applicants who submit certain new drug and biological product applications. FDA was first authorized to collect user fees under the Prescription Drug User Fee Act (PDUFA) of 1992.