Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic.
Act of Parliament | Act | Food and Drug Administration | Statute Law Revision Act 1948 | Drug Enforcement Administration | Restoration | Statute Law Revision Act 1888 | Vincent Price | patent | drug | The Price Is Right | Bourbon Restoration | United States Patent and Trademark Office | Act of Congress | Food and Drug Administration (United States) | Reform Act 1832 | Patient Protection and Affordable Care Act | Endangered Species Act | Digital Millennium Copyright Act | Clean Water Act | American Recovery and Reinvestment Act of 2009 | National School Lunch Act | Statute Law Revision Act 1863 | Illegal drug trade | Criminal Justice Act 1988 | Victorian restoration | Local Government Act 1972 | Americans with Disabilities Act of 1990 | Meiji Restoration | cannabis (drug) |
The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) of 1984 provides patent holders on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining Food and Drug Administration (FDA) approval.