New FDA Product-Specific Draft Guidances Available for Generic Drug Development

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals.

These PSGs describe the agency’s current thinking and expectations on how to develop generics that are therapeutically equivalent to the reference listed drug.

Issuing these PSGs is among the commitments included in GDUFA III, which the agency will prioritize based on public health priorities, drug availability and accessibility, public requests for guidance, stakeholder interest in ANDA submission.

Access the new and newly revised PSGs here.

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