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Congress Urges More FDA Attention to Rare Diseases

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A bipartisan group of U.S. Senators and House members call on FDA to step up its regulatory activities to improve rare disease pro...

Astellas Gets Approval for Menopause Drug

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FDA approves Astellas Pharmas Veozah (fezolinetant), an oral drug for treating moderate-to-severe vasomotor symptoms caused by men...

FDA Encourages Voluntary Device Shortage Notices

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Due to its authority having expired on 5/11 with the end of the Covid-10 public health emergency (PHE), FDA now urges medical devi...

FDA Eases Blood Donor HIV Recommendations

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FDA eases its recommendations for evaluating potential blood donors for HIV.

Cook Tracheostomy Introducer Recall is Class 1

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FDA says a Cook Medical 4/7 recall of a tracheostomy introducer is Class 1.

FDA OKs Rexulti for Alzheimers Agitation

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FDA approves an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpriprazole) oral tablets for treating agitati...

More Groups, Experts Back KEI Ad Music Petition

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Three stakeholder groups and seven individuals call for FDA to promptly approve a Knowledge Ecology International 2020 petition to...

FDA Planning for Future Public Health Issues

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FDA commissioner Robert Califf and chief medical officer Hilary Marston describe ways the agency will be better able to address fu...

Paper on Artificial Intelligency/Machine Learning

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Federal Register notice: FDA releases a discussion paper entitled Using Artificial Intelligence (AI) and Machine Learning (ML) in ...

Hydrochlorothiazide Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Roxane Laboratories hydrochlorothiazide oral solution was not withdrawn from sale due...