FDA Issues A Raft Of Product-Specific Guidances

Set Of 36 Guidances Includes 19 New And 17 Revised Documents

02 Sep 2020

The FDA has issued 36 draft product-specific guidances for generic drug development, comprising 19 new guidances and 17 revised documents.

The FDA Has Issued 36 New And Revised Product-Specific Guidances • Source: Shutterstock

A raft of fresh product-specific guidances for generic drug development has been published by the US Food and Drug Administration at the start of September, with the 36 draft guidances published by the agency offering 19 new PSGs and 17 revised documents.

Among the new draft PSGs are documents covering amlodipine suspension, injectable bortezomib and lefamulin and gallium DOTATOC Ga 68...