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Evofem Biosciences Ends STI Drug Development

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Evofem Biosciences discontinues its EVO100 development program of a drug to prevent chlamydia and gonorrhea in women.

17 Observations on Empower Pharmacy FDA-483

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FDA releases the form FDA-483 with 17 observations from an inspection at the Houston, TX-based Empower Pharmacy outsourcing facili...

Rolling NDA Filed for OTC Opioid Overdose

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Harm Reduction Therapeutics submits the first module of a planned rolling NDA for RiVive (3 mg intranasal naloxone), indicated as ...

Medical Device User Fee Rates Set

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Federal Register notice: FDA announces the user fee rates for fiscal year 2023 for medical devices.

Is FDA Relying More on Confirmatory Evidence?

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Three Hyman, Phelps & McNamara attorneys say several recent drug approvals appear to signal a new FDA interest in using confirmato...

Merck, Moderna Developing Personalized Cancer Vaccine

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Merck exercises an option to collaborate with Moderna on a personalized cancer vaccine currently being evaluated in a Phase 2 tria...

Chinese Firm Recalls Unauthorized Covid-19 Tests

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Jiangsu Well Biotech (Jiang Su Sheng, China) recalls its Covid-19 Ag Rapid Test Devices because they were distributed without auth...

FDA Launches TAP Pilot

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FDA says CDRH is launching the Total Product Life Cycle Advisory Program (TAP) pilot program called for in the MDUFA 5 reauthoriza...

Legacy Pharmaceutical CGMP Violations

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FDA warns Earth City, MO-based Legacy Pharmaceutical Packaging about CGMP violations and insanitary conditions in its manufacturin...

Comment Deadline Extended for LASIK Labeling Guidance

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FDA extends the deadline for comments on a draft guidance intended to improve labeling for LASIK devices used in vision correction...