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FDA Unveils Device Development Advisory Pilot

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Federal Register notice: FDA announces a voluntary Total Product Life Cycle Advisory Program pilot that was agreed to between FDA ...

FDA Lowers Covid Bivalent Booster Age

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FDA expands the emergency use authorization for the Moderna and Pfizer/BioNTech bivalent Covid vaccine booster shots to cover chil...

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...