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Hi-Tech Files DMAA Appeal

[ Price : $8.95]

Hi-Tech Pharmaceuticals asks the 11th Circuit Court of Appeals to rule that its synthetic DMAA, an amphetamine derivative, is a le...

FDA Clears Quantel Easyret Eye Laser

[ Price : $8.95]

FDA approves a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certa...

Intellipharmaceutics Working to Remedy FDA Rexista Concerns

[ Price : $8.95]

Intellipharmaceutics says it will try to resolve concerns raised by FDA advisors about its Rexista abuse-deterrent opioid.

New FDA Digital Health Steps

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FDA commissioner Scott Gottlieb announces two new CDRH initiatives to develop more appropriate regulatory approaches to digital he...

FDA Re-org Outlines Oncology Center of Excellence Role

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Federal Register notice: FDA announces a new organizational structure for the Office of the Medical Products and Tobacco to establ...

Guidance on FDA accepting Gifts on Behalf of U.S.

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Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Comments Sought on Device Pediatric Info Collection

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Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Pediatric Uses of Devices; Re...

Guidance on CVM Blood Level Bioequivalence Studies

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.

Guidance on FDA accepting Gifts on Behalf of U.S.

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Agios Pharma Stops Drug Development After FDA Hold

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Agios Pharmaceuticals pulls the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and with...