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Federal Register notice: FDA sends to OMB an information collection entitled Records and Reports Concerning Experiences with Appro...[ Price : $8.95]
Sen. Kirsten Gillibrand introduces the bipartisan Promising Pathways Act to permit FDA provisional approval of some drugs for life...[ Price : $8.95]
The Parenteral Drug Association says its members still have many questions about CDERs Quality Management Maturity program and rec...[ Price : $8.95]
FDA clears two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice D...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says it will research issues involving the use of endorsers in prescription drug TV...[ Price : $8.95]
Lilly says it expects to make a regulatory submission in the coming weeks for its tirzepatide for weight loss in adults with obesi...[ Price : $8.95]
FDA publishes a guidance with general standards for registering with the CVM electronic submission system.[ Price : $8.95]
CorMedix says it will resubmit an NDA for its DefenCath within the next few weeks.