Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)

Issue Date: March 2, 1998
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Final

Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)

This letter provides some information on how FDA intends to implement the Drug Price Competition and Patent Term Restoration Act.

Download the Guidance Document

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