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Draft Guide on Biosimilar/Interchangeable Labeling

[ Price : $8.95]

FDA posts a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Products.

FDA Extends BLA Review of Melanoma Therapy

[ Price : $8.95]

FDA extends by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte the...

Guide on Drug Postmarketing Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Annual Status Report Information and Other Submissions for ...

2 Draft Guides on Weight Loss Devices

[ Price : $8.95]

Federal Register notice: FDA makes available two draft guidances on clinical and non-clinical study recommendations for medical de...

Final Guide on Device Improvement Program

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Fostering Medical Device Improvement: Food and Drug Adminis...

Guide on Breakthrough Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Breakthrough Devices Program.

Digital Health Frequently Asked Questions

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CDRH develops a Digital Health Frequently Asked Questions Web page to help developers bring innovative technologies to market.

Beacon Biosignals 510(k) for Sleep Monitor

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FDA clears a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine learning algorithms to capture...

FDA OKs GSKs Blood Cancer Drug

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FDA approves GlaxoSmithKlines NDA Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis.

Voluntary Improvement Program Guidance

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FDA publishes a guidance with its policy on participating in the medical device Voluntary Improvement Program.