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FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...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

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FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...

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 ...

Cochlear Osia 2 Hearing Implant Cleared

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FDA clears a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant.