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FDA Says Adderall is in Shortage

[ Price : $8.95]

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Federal Register notice: FDA extends the comment period for a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK...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

Evofem Biosciences Ends STI Drug Development

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Evofem Biosciences discontinues its EVO100 development program of a drug to prevent chlamydia and gonorrhea in women.

17 Observations on Empower Pharmacy FDA-483

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FDA releases the form FDA-483 with 17 observations from an inspection at the Houston, TX-based Empower Pharmacy outsourcing facili...