FDA releases draft guidance on information requests and discipline review letters

The US Food and Drug Administration (FDA) has released draft guidance which establishes a new type of letter the agency sends to generic drug manufacturers to provide applicants with initial thoughts on possible deficiencies of an abbreviated new drug application (ANDA). The FDA will issue discipline review letters (DLRs) and information requests (IRs) to attain further information or clarification to ensure completion of a discipline review. Read more “FDA releases draft guidance on information requests and discipline review letters”