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Guide on Testing Pharmaceutical Alcohols

[ Price : $8.95]

FDA publishes a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.

Guidance on Diabetic Foot Infection Drugs

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FDA posts a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.

Zofran Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Sandozs Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not...

Aldeyra Tussles With FDA on NDA Data

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Aldeyra Therapeutics says it is addressing substantive late review-cycle concerns raised by FDA on the companys NDA for reproxalap...

GE HealthCare Update on Neonatal Incubators

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An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher l...

Priority Review for Tagrisso sNDA in Lung Cancer

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FDA accepts for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for tr...

SentiAR 3D Holographic Headset Cleared

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FDA clears a SentiAR 510(k) for its CommandEP, which the company says integrates existing 3D cardiac mapping systems to create a r...

Device Inspection Compliance Program Revised

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FDA updates its (XXX DELETE EXTRA SPACE XXX)Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers,...

Hogan Lovells Skeptical of New Generics Pilot

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A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integra...

FDA OKs Pfizer Ulcerative Colitis Drug

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FDA approves a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for...