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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Lee Silsby Compounding Pharmacy.

AbbVie NDA for Endometriosis Pain Drug Approved

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FDA approves an AbbVie NDA for Orilissa (elagolix), the first oral gonadotropin-releasing hormone antagonist specifically develope...

Draft Guide on Inborn Errors of Metabolism

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Federal Register notice: FDA makes available a draft guidance entitled Inborn Errors of Metabolism That Use Dietary Management: Co...

Liquid, Soft Food Drug Vehicle Guidance

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FDA publishes a draft guidance on using liquids and soft foods as a drug administration vehicle.

FDA Acts on Cesium Chloride Same Day Lawsuit Filed

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On the same day Public Citizen filed a lawsuit against it, FDA 7/23 partially grants the activist groups objective: a ban on cesiu...

Draft Guide on Inborn Errors of Metabolism Drugs

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FDA posts a draft guidance on Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardi...

Medi-Lynxs PocketECG Cardiac Rehab System Cleared

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FDA clears a Medi-Lynx Cardiac Monitoring 510(k) for the PocketECG Cardiac Rehabilitation System, a mobile cardiac rehabilitation ...

Allergan Gets Fast Track Status for Antidepressant

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FDA grants Allergan a fast track designation for AGN-241751, an investigational new treatment for major depressive disorder.

Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan Filed

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FDA accepts for review an Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.00...

More Guides for ANDA Bioequivalence Study Designs

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-sp...