FDA Spells Out Its Commitments on Product-Specific Guidance Meetings

The FDA has released new details for companies preparing to submit an abbreviated new drug application (ANDA) on how to request meetings relating to a new or revised product-specific guidance (PSG) that may impact their application.

PSGs describe the FDA’s current thinking on the evidence needed to demonstrate that an ANDA is therapeutically equivalent to a specific reference product.

In a 23-page draft guidance, the agency offered updated timeframes and procedures for requesting PSG teleconferences as well as presubmission and postsubmission meetings.

ANDA applicants should submit a request for a PSG teleconference within 60 days after publication of a new or revised PSG so that the FDA can provide timely feedback, the agency said.

Comments on the draft guidance are due to the FDA by April 16.