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Senate Report Raises Questions About Oversight of Mifepristone Providers

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A new report from Senate HELP chair Bill Cassidy (R-LA) targets FDA for allowing the abortion drug mifepristones Risk Evaluation a...

Boebert Bill to Ease Botanical Drug Development

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Rep. Lauren Boebert introduces legislation to remove some barriers to the development of botanical drugs.

Support, Suggestions for Expedited IND Pilot

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Five stakeholders support an FDA proposal for an expedited IND pilot program and suggest ways to improve it.

HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

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CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

Boston Scientific ENROUTE System Recall is Class 1

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FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

Do More to Capture Nonprescription Drug Use Info: Meeting

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Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to improve the electronic health recor...

Osfamide Shortage Seen

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An oncology physician association says its members are reporting a shortage of the chemotherapy agent ifosfamide for which no dire...

FDA Issues Alert on Abiomed Impella Controllers

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CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers be rem...

Petition Seeks Carbetocin OK for Postpartum Hemorrhage

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Two physicians affiliated with Stanford Universitys medical school urge FDA to approve carbetocin for preventing postpartum hemorr...

Celcuity Files sNDA for Revtorpyk Expanded Use

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Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human ...