Federal Register notice: FDA sends to OMB an information collection entitled Records and Reports Concerning Experiences with Approved New Animal Drugs...
Sen. Kirsten Gillibrand introduces the bipartisan Promising Pathways Act to permit FDA provisional approval of some drugs for life-threatening disease...
The Parenteral Drug Association says its members still have many questions about CDERs Quality Management Maturity program and recommendations to impr...
FDA clears two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice Dressing.
FDA publishes a guidance with general standards for registering with the CVM electronic submission system.
CorMedix says it will resubmit an NDA for its DefenCath within the next few weeks.
Harvard Medical School researchers say it is possible for database studies to emulate randomized clinical trials to show how medications work in clini...
Novartis says it is planning a regulatory submission to FDA and other agencies worldwide in the first half of this year for iptocopan to treat paroxys...
