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FDA Seeks Covis Info for Makena Hearing

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CDER asks an FDA hearing officer to direct Covis to provide additional information on items from its final briefing materials for ...

GSK Respiratory Syncytial Virus Vaccine Highly Efficacious

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GlaxoSmithKline says its investigational adult respiratory syncytial virus vaccine candidate was highly effective in a Phase 3 tri...

FDA Says Adderall is in Shortage

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FDA says Teva manufacturing delays have led to a shortage of Adderalls immediate-release formulation.

CMC Comparability Protocol Guidance

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FDA publishes a final guidance on using comparability protocols for postapproval changes in chemistry, manufacturing, and controls...

Distributed Manufacturing Discussion Paper

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FDA solicits input on a discussion paper raising regulatory issues and questions about direct manufacturing and point-of-care manu...

OPDP Wants to Research Drug Name Interpretation

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The CDER Office of Prescription Drug Promotion says it wants to research how consumers and healthcare providers interpret prescrip...

Regener-Eyes Illegally Selling Dry Eye Product

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FDA says Palm Harbor, FL-based Regener-Eyes is illegally marketing its Regener-Eyes Ophthalmic Solution.

FDA Extends Comment Period on LASIK Labeling Guide

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Federal Register notice: FDA extends the comment period for a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK...

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...