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FDA Raises Approval Standards for CAR-T Cancer Therapies

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CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on...

Potential Redefinition of Enforcement Boundaries: Attorneys

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Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially invol...

CGMP Issues at Seaway Pharma

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FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract ma...

First Approval Under New Priority Voucher Program

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FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program...

FDA Qualifies 1st AI Drug Development Tool

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FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated stea...

FDA Issues Promotional Guide for Biosimilars/Reference Biologics

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FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Prod...

FDA Says Looking at Safety of RSV Infant Therapies

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FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.

Envoy Medical QS Violations

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FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hea...

FDA Broadens Covid Vaccine Probe to Include Adult Deaths

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FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric d...

Experts Call for Overhaul of FDA Revolving Door Rules

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Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into p...