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Optical Lens Maker Pays $16.4 Million Over False Claims

[ Price : $8.95]

Essilor International (Dallas, TX) agrees to pay $16.4 million to resolve allegations that it violated the False Claims Act by pay...

Panel to Vote on Ipsen NDA for Palovarotene

[ Price : $8.95]

Federal Register notice: FDA announces a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting.

OMB Approves 11 FDA Info Collections

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Federal Register notice: FDA posts a notification that OMB has approved 11 recent information collections.

CDER to Discuss Quality Management Maturity at Meeting

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CDER plans to review and discuss its proposed Quality Management Maturity program at an 11/2 advisory committee meeting.

Alert on Autoinjectors with Multiple Sclerosis Drugs

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FDA issues a safety alert on autoinjector devices that are optional for use with multiple sclerosis therapy glatiramer acetate inj...

FDA Hold on Pharvaris Hereditary Angioedema Therapy

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FDA issues Pharvaris a clinical hold on two clinical trials of its PHA121, an oral bradykini B2-receptor antagonist for treating a...

Draft Guide on Charging for Investigational Drugs

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FDA releases a revised draft guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.

Koag Vascular Closure Pad Cleared

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FDA clears a Koag 510(k) for its Vascette HP device, a topical vascular closure pad that uses a proprietary, plant-derived hemosta...

NIHs Fauci Stepping Down At End of Year

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After 38 years as National Institute of Allergy and Infectious Diseases (NIAID) director, Anthony Fauci says he will be stepping d...

Pfizer/BioNTech Seek EUA for New Booster Vaccine

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Pfizer and BioNTech file a submission seeking FDA Emergency Use Authorization for their booster dose of an Omicron BA.4/BA.5-adapt...