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Public Citizen Sues FDA to Force SSRIs Decision

[ Price : $8.95]

Public Citizen sues FDA to force it to act on a six-year-old petition seeking labeling changes for SSRIs and SNRIs to highlight th...

Hologic BioZorb Marker Recall is Class 1

[ Price : $8.95]

FDA says the Hologic recall (correction) of BioZorb markers is Class 1.

Magellan Pays $40 Million Over Faulty Devices

[ Price : $8.95]

Magellan Diagnostics (Billerica, MA) agrees to pay $40 million to resolve criminal charges relating to its concealment of a device...

PhRMA Supports Post-Approval Safety Guidance

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PhRMA says it supports FDA and the International Council for Harmonization revision of the E2D guidance on post-approval case safe...

Evaluating Immunosuppressive Effects in Drugs Workshop

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Federal Register notice: FDA announces a 7/11 public workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure t...

Survey on Increasing Pediatric Devices

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Federal Register notice: FDA reinstates an information collection entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Sc...

Multiple Violations in Akan Bio's Ayama

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FDA warns Gaithersburg, MD-based Akan Biosciences about multiple violations in its manufacturing and distribution of Ayama, an adi...

GSK Reports Positive Data from Asthma Trials

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GSK says two Phase 3 clinical trials evaluating severe asthma treatment hopeful depemokimab met their primary endpoints of reducin...

Covid Panel Meets 6/4 on 2025 Vaccine

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Federal Register notice: FDA announces that its previously postponed 5/16 meeting of the Vaccines and Related Biological Products ...

Hill Moves to Repeal FDA Rule on LDTs

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Sen. Rand Paul and Rep. Brad Finstad introduce a Congressional Review Act resolution to block an FDA proposed rule on oversight of...