FDA Solicits Comments on Drug Products Approved Ahead of Hatch-Waxman Amendments

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FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

FDA has opened a public docket to solicit comments on issues relating to FDA post-approval regulation of drug products that were approved under abbreviated new drug applications (ANDAs) before the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments), which established the current ANDA process.

Since 1938, drug approvals were regulated through the FD&C Act, but in 1984, the Hatch-Waxman Amendments added sections 505(b)(2) and 505(j) to the FD&C Act, which introduced the current pathways for new drug applications (NDAs) and ANDAs, respectively.

Because ANDAs approved between 1938 and 1984 (PANDAs) were implemented without the Hatch-Waxman Amendments in place, the rules surrounding their regulation differ from contemporary ANDAs. This difference has led to questions surrounding how to best handle PANDAs, which have historically been overseen by FDA’s Office of Generic Drugs, in relation to contemporary ANDAs.

For example, because PANDAs were instituted before the Hatch-Waxman Amendments and were submitted under Section 505(b) and approved under Section 505(c), they can serve as a reference listed drug (RLD) for generic drugs submitted as an ANDA or NDA. According to the FDA docket, this has led to “some confusion about the applicability of certain statutory and regulatory provisions” among applicants.


FDA will solicit feedback from interested parties until December 13, 2021. For more detailed submission guidelines, you can view their guidelines here.

Source: FDA