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Marketing

FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDAs intensified scrutiny of drug advertising, advising companies to prepare for clos...

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Human Drugs

Senate Report Raises Questions About Oversight of Mifepristone Providers

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

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Human Drugs

Boebert Bill to Ease Botanical Drug Development

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

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Human Drugs

Support, Suggestions for Expedited IND Pilot

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

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Human Drugs

Osfamide Shortage Seen

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

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Medical Devices

FDA Issues Alert on Abiomed Impella Controllers

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

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Human Drugs

Petition Seeks Carbetocin OK for Postpartum Hemorrhage

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

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FDA General

HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

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

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Medical Devices

Boston Scientific ENROUTE System Recall is Class 1

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

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Human Drugs

Do More to Capture Nonprescription Drug Use Info: Meeting

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