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EIRS/483s

Attorneys Dismiss Hype on FDORA Animal Testing Provision

Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change on preclinical animal testing may not be as monume...

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Human Drugs

Man Fakes Cancer to Skip FDA Misbranding Trial

An FDA criminal case involving a Mays Landing, NJ, man who marketed a toxic chemical as a weight-loss drug online has led to a guilty plea on an obstr...

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Medical Devices

Device Conformity Assessment Pilot Becoming Permanent

CDRHs Accreditation Scheme For Conformity Assessment pilot program transitions to a permanent program based on review efficiencies it has demonstrate...

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Human Drugs

Trodelvy OKd for Pre-treated Metastatic Breast Cancer

FDA approves a Gilead Sciences supplemental BLA for Trodelvy for treating certain adult patients breast cancer who have received endocrine-based thera...

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Medical Devices

Device Co. Pays $500K over False Claims: DoJ

Medical device manufacturer Joint Active Systems (Effingham, IL) agrees to pay $500,000 under a Justice Department settlement over False Claims Act vi...

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Human Drugs

Senators Urge Danco Labs to Expand Mifepristones Use

Senator Jeanne Shaheen (D-NH) leads a group of Senators in sending a letter to Danco Laboratories, a manufacturer of mifepristone, urging it to submit...

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Human Drugs

FDA Clinical Hold on 4D Molecular Fabry Drug

FDA places a clinical hold on 4D Molecular Therapeutics 4D-310 drug therapy being studied for treating Fabry Disease Cardiomyopathy after the company ...

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Federal Register

Annual Postmarketing Requirements Report Posted

Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...

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Human Drugs

FDA Corrects Notice on ANDA Withdrawals

Federal Register notice: FDA corrects an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple applicants.

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Federal Register

Fraudulent Contract Research Org. Leads to Debarment

Federal Register notice: FDA issues debarment order against Sami Anwar that bars him from providing services related to an approved or pending drug pr...