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FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...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

House Passes Drug Pricing Bill

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The House approves drug pricing legislation that is likely to die in the Senate or face a presidential veto.

Provention Bio Plans Rolling BLA for 2020

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Provention Bio says it is planning a rolling BLA application for its Type 1 diabetes drug teplizumab in 2020.

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FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...

Courts Could See FDA Warning Letter as Final Action

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Attorney Michelle Yeary says a DC federal court decision might open the way for FDA Warning Letters to be considered final agency ...

CRN Praises Court Decision in Fish Oil Case

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The Council for Responsible Nutrition praises the Supreme Courts refusal to hear an Amrin appeal of a fish oil dietary supplement ...

Briviact Injection/Solution Regulatory Review Period

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Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact oral solution ...