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No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

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Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time ...

WLF Warns on New DTC Ad Rules Violating First Amendment

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The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical adv...

FDA OKs 1st Gene Therapy for Wiskott-Aldrich Syndrome

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FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskot...

Revoke All mRNA Covid Vaccine BLAs: CHD Petition

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Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not ...

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...

Prescription to Nonprescription Switch MAPP

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CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription mar...

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...