FDA Issues 48 Product-Specific Guidances for Generic Drug Development
The FDA has issued 29 new draft and 19 revised draft product-specific guidances meant to foster generic drug development and Abbreviated New Drug Application (ANDA) approvals.
The guidances, which offer advice for the design of bioequivalence studies to support ANDAs, include 28 for reference products that currently lack any approved generics.
In June 2010, the FDA issued a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process it would use to make the product-specific guidances available on its website.
The agency invited comments on the draft documents by Oct. 3. Access the list here: bit.ly/3d3RMpT.
August 4, 2022
