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Addrenex Submits sNDA to Treat ADHD

[ Price : $8.95]

Addrenex Pharmaceuticals submits an sNDA to FDA for Clonicel to treat attention deficit hyperactivity disorder.

Heparin Manufacturing Change Decreases Potency

[ Price : $8.95]

FDA announces changes in heparin manufacturing controls mandated by USP that will cause a drop in drug potency with clinical impli...

Penumbra Recalls Delivery Catheter

[ Price : $8.95]

FDA says Penumbra has recalled its original version of the Neuron 6F 070 Delivery Catheter due to reports that it could kink in ce...

FDA Releases Risk Communication Strategic Plan

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FDA releases a strategic plan for improving risk communications over the next several years.

Discovery Labs and FDA Address Surfaxin NDA Hurdles

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Discovery Laboratories says it and FDA held a teleconference 9/29 that established an approach to potentially resolve the remainin...

FDA Clears Covidien Endo Tube

[ Price : $8.95]

FDA clears a Covidien 510(k) for its Mallinckrodt TaperGuard Evac endotracheal tube.

FDA Not Waiting for Studies to Strengthen 510(k) Procedures

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CDRHs Office of Device Evaluation moves swiftly to strengthen its heavily criticized 510(k) program, fanning industry fears of a r...

Dr. Reddys Recalls 4 Drugs in U.S.

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Dr. Reddys recalls four products marketed in the U.S. due to the presence of oversized tablets in some lots.

FDA Draft Guide on REMS Format

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FDA releases a new draft guidance to help drug and biologic sponsors prepare a proposed risk evaluation and mitigation strategy (R...

Companies Need to Meet FDA Data Integrity Expectations

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FDA regulatory compliance consultant John Avellanet says companies need to take steps to ensure they are prepared for FDA examinat...