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Comments Sought on 8 Drugs for WHO Scheduling

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Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for me...

Guide on Nitrosamine Acceptable Intake Limits

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Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug S...

Drger Recalls Carina Ventilators

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Drgerwerk recalls its Drger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas.

Orphan Status for BRAF Inhibitor

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FDA grants ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients w...

Sage Postpartum Depression Oral Drug Approved

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FDA approves a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression in adults.

Draft Guide on Cosmetic Registration/Listing

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FDA issues a draft guidance entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry. ...

Astellas Eye Drug Approved by FDA

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FDA approves an Astellas Pharmas Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy secondary to a...

FDA Clears Abbotts Hematology Device

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FDA clears an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts.

Guide on Drug Supply Chain Security

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Federal Register notice: FDA makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements o...

K-TAB Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety o...