FDA Guides On Generic Product-Specific Meetings, Under GDUFA III Commitment
PSG Teleconferences, Pre-Submission And Post-Submission Meetings In Draft Guide
With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.
