BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 16/10/2017

FDA Announces Draft Guidance for Industry on Post-Complete Response Letter Meetings

The FDA is releasing a draft guidance to clarify the criteria for post-complete response letter meeting requests and ensure well-managed meetings under the Generic Drug User Fee Act (GDUFA).

Source: Federal Register — Food and Drug AdministrationOpen original release →