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...
Federal Register notice: FDA seeks comments on an information collection extension Animal Drug and Animal Generic Drug User Fee Programs.
FDA releases the form FDA-483 with eight observations from an inspection at Reykjavik, Iceland-based Alvotech Hf.
Akorn through its bankruptcy (Chapter 7) trustee recalls various within-expiry human and animal products because the company has ceased all operations...
