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Gillibrand Bill to Speed FDA Approval of Some Drugs

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Sen. Kirsten Gillibrand introduces the bipartisan Promising Pathways Act to permit FDA provisional approval of some drugs for life...

Quality Management Maturity Dividing Industry: PDA

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The Parenteral Drug Association says its members still have many questions about CDERs Quality Management Maturity program and rec...

FDA Clears 2 Wound Dressings from 3M Health

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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...

FDA Planning TV Ad Endorser Research

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The CDER Office of Prescription Drug Promotion says it will research issues involving the use of endorsers in prescription drug TV...

Lilly Planning Tirzepatide Submission Soon

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Lilly says it expects to make a regulatory submission in the coming weeks for its tirzepatide for weight loss in adults with obesi...

CVM Electronic Submission Registration

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FDA publishes a guidance with general standards for registering with the CVM electronic submission system.

DefenCath NDA to be Resubmitted by Mid-May

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CorMedix says it will resubmit an NDA for its DefenCath within the next few weeks.

Nonrandom Data Can Emulate Random Trials: Study

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Harvard Medical School researchers say it is possible for database studies to emulate randomized clinical trials to show how medic...

Iptacopan FDA Submission Coming Soon: Novartis

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Novartis says it is planning a regulatory submission to FDA and other agencies worldwide in the first half of this year for iptoco...

Animal Drug User Fee Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension Animal Drug and Animal Generic Drug User Fee Pr...