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Draft Guide on Pediatric Oncology Drugs

[ Price : $8.95]

Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly...

Futura to Seek FDA Placebo Pathway for ED

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Futura Medical says it intends to discuss with FDA a medical device regulatory approval pathway for the placebo arm from an erecti...

Industy Reps Sought for Mammography Panel

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Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...

FDA Qualifies MRI Compatibility, Safety Software

[ Price : $8.95]

FDA qualifies the first computational modeling tool to be used with a wide range of implantable active medical devices through the...

Seven Observations on Exela FDA-483

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FDA releases an FDA-483 with seven observations from an inspection at the Exela Pharma Sciences outsourcing facility.

Webinar on FDA-3542 and FDA-3542a Updates

[ Price : $8.95]

A CDER Webinar explains updates to forms FDA-3542a and 3542 and instructs participants on how to complete the forms.

Draft Pediatric Oncology Studies Guidance

[ Price : $8.95]

FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...

Senate Confirms Hahn as Next FDA Commissioner

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The Senate confirms Stephen Hahn as the next FDA commissioner on a floor vote of 72-18.

Newborn Test for Duchennes Cleared for Use

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FDA authorizes the de novo marketing of PerkinElmers GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchen...

Elite Pharmaceuticals ANDA for Generic Adderall XR

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FDA approves an Elite Pharmaceuticals ANDA for a generic version of Shires Adderall XR, indicated for treating attention deficit h...