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FDA Reports Coronavirus-caused Drug Shortage

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FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected b...

Generics Group Opposes Changes to 180-day Exclusivity

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The Association for Accessible Medications steps up pressure on Congress to reject legislation to change FDAs 180-day marketing ex...

FDA OKs Esperions Combo Cholesterol Drug

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FDA approves an Esperion NDA for Nexlizet (bempedoic acid and ezetimibe) as an adjunct to diet and maximally tolerated statin ther...

Pilot on Drug Guidance Snapshots

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FDA launches a new pilot program to simplify public awareness about guidance documents that seek to modernize drug clinical trials...

Companion Medical InPen Insulin Calculator Cleared

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FDA clears a Companion Medical 510(k) for its InPen bolus insulin calculator for fixed dosing and meal estimation.

Cerovene Generic Daraprim Approved

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FDA approves a Cerovene ANDA for the first generic copy of Vyera Pharmaceuticals Daraprim (pyrimethamine) tablets for treating tox...

Baxter Peri-Strips Dry with Secure Grip Cleared

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FDA clears a Baxter International 510(k) for its Peri-Strips Dry with Veritas Collagen Matrix, a staple line reinforcement materia...

CDRH 510(k) eSubmission Template Pilot

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Federal Register notice: CDRH has announced a voluntary Electronic Submission Template and Resource (eSTAR) Pilot.

Standardized Medicated Feed Assay Limits Guide

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Federal Register notice: FDA makes available a draft guidance for industry #264 entitled Standardized Medicated Feed Assay Limits....

Comments on Combination Product Draft Guidance

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PhRMA and AdvaMed suggest changes to an FDA draft guidance on feedback on combination products.