New and revised product-specific guidance from the FDA

The US Food and Drug Administration (FDA) has recently issued 36 new and revised draft product-specific guidances. These documents are published with the aim of fostering drug product development to increase public access to safe, affordable generic drugs.

Whenever an applicant wishes to develop and manufacture a generic drug product, they must demonstrate bioequivalence (BE) to a reference listed drug (RLD). Whilst the FDA has published guidance documents for industry on conducting bioequivalence studies, product-specific guidances are issued to further facility the availability of generic drugs. These documents help manufacturers understand the agency’s expectations with regard to the appropriate method for developing drugs and generating the necessary evidence to support Abbreviated New Drug Application (ANDA) approval.

22 new and 14 revised documents have been published. Click here to view all of the latest product-specific guidance documents.