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FDA Withdraws Approval for 4 B. Braun Medical Drugs

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Federal Register notice: FDA announces that it is withdrawing approval of three NDAs and one ANDA held by B. Braun Medical.

FDA Approves Jazz Vyxeos for 2 AML Cancers

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FDA approves Jazz Pharmaceuticals Vyexos to treat two high-risk types of acute myeloid leukemia.

Rugby Laboratories Recalls Diocto Liquid and Syrup

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FDA says Rugby Laboratories is recalling all lots of Diocto Liquid and Dicoto Syrup manufactured by PharmaTech due to possible con...

FDA Panel Thumbs Down on Janssen Arthritis Drug

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FDAs Arthritis Advisory Committee votes 12 to 1 against recommending approval of a Janssen Biotech BLA for Plivensia (sirukumab), ...

Jenkins Delayed Retirement to Protect Drug Reviews from Woodcock

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A new email released under a lawsuit against FDA shows that former Office of New Drugs director John Jenkins delayed his planned r...

Senate Passes User Fee Reauthorization Bill

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The Senate passes an FDA user fee reauthorization bill to fund agency product reviews and related activities for the next five yea...

Randomized Clinical Trial Alternatives Explored

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Former CDC director Thomas Frieden says researchers need to be open to using new methods that may work better than randomized clin...

2 FDA REMS Updates Announced

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FDA announces updates to the REMS@FDA Web site.

New DoJ Opioid Fraud and Abuse Detection Unit

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Attorney General Jeff Sessions announces formation of a pilot program to use data to help combat the nations opioid crisis.

FDA Webinar on OTC Monograph User Fees

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Federal Register notice: FDA announces an 8/23 Webinar to provide stakeholders with a status update on the process of FDA and indu...