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2 Pediatric Drug Approval Guidances

[ Price : $8.95]

FDA publishes two guidances to assist in the development of drugs, biologics, and vaccines for pediatric use.

Partial Hold Modified in Myotonic Dystrophy Study

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FDA modifies a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of ...

ICU Medical Recalls Pumps Over Battery Defect

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ICU Medical recalls the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a bat...

Susceptibility Test Interpretive Criteria Updated

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Federal Register notice: FDA posts its annual compilation of notices of updates to the agencys antimicrobial test interpretive cri...

Device Panel to Tackle Health Equity

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Federal Register notice: CDRH plans a 9/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations...

Reviewers Question Intercepts Liver Drug

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FDA asks the Gastrointestinal Drugs Advisory Committee whether it recommends approval of Intercepts obeticholic acid to treat pre-...

Bill to Use Industry Penalties for Cancer Research

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A bipartisan group of members of Congress introduce legislation to redirect penalties paid by drug, cosmetic, supplement, and medi...

Califf Hopeful on Alzheimers, Obesity Drug Data

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FDA commissioner Robert Califf tells the Food and Law Institutes annual meeting that the U.S. could be on the verge of seeing majo...

Drug Company Patent Violations Cost $40 Billion: Study

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The American Economic Liberties Project and the Initiative for Medicine, Access, and Knowledge recommend policy changes to curb dr...

Reject Apotex Generic Fintepla ANDA: UCB

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UCB petitions FDA not to approve an Apotex ANDA for generic Fintepla unless its labeling includes specified information from the r...