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Consider DaVinci Cautery Instrument Ban: Petition

[ Price : $8.95]

Unplug the Robot activist Jennifer Nelson asks FDA to consider banning and recalling all DaVinci Robot permanent cautery instrumen...

Guide on Drug Packaging and Labeling Terms

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Selection of the Appropriate Package Type Terms and Recomme...

Draft Guide on ANDA Blocking Petitions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Citizen Petitions and Petitions for Stay of Action Subject ...

CDRH Plans 21 Guidances This Year

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CDRH issues a list of 21 final and draft gudiances it expects to publish in FY 2019.

Glaxo Resuming Some Doctor Payments

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GlaxoSmithKline reverses a 2013 policy and will pay some doctors for promoting some of its drugs.

FDA Clears CarboFix Carbon Fiber Connectors

[ Price : $8.95]

FDA clears a CarboFix in Orthopedics 510(k) for the CarboClear Carbon Fiber Transverse Connectors to be used in conjunction with i...

Liveyon Recalls Stem Cell Product

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Liveyon recalls all ReGen Series stem cells due to reported adverse reactions.

Guide on Atopic Dermatitis Pediatric Studies

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Federal Register notice: FDA makes available a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development...

Fast Track for VistaGen Non-opioid Pain Killer

[ Price : $8.95]

FDA grants VistaGen Therapeutics a fast track designation for AV-101, a non-opioid, non-sedating treatment for neuropathic pain.