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DoJ urges High Court Review of Skinny-Label Dispute

[ Price : $8.95]

The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face...

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 ...

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...

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...