Draft Guidance for Industry on Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines." This draft guidance is intended to assist applicants and other responsible parties in fulfilling FDA's postmarketing safety reporting requirements for marketed human drugs and biological products.