FDA Guides On Generic Product-Specific Meetings, Under GDUFA III Commitment
PSG Teleconferences, Pre-Submission And Post-Submission Meetings In Draft Guide
Executive Summary
With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.
You may also be interested in...
Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.
Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks to Generics Bulletin about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.
Generic Drugs Outlined As ‘Significant Public Health Priority’ For FDA
The FDA Office of Generic Drugs has published its annual report, highlighting its contributions to the approval of Viatris’ generic cyclosporine rival to Restasis, alongside updates to bioequivalence standards and support for competition.