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Gene Therapy Guide on NonClinical Biodistribution

[ Price : $8.95]

FDA posts an International Council for Harmonization final guidance entitled S12 Nonclinical Biodistribution (BD) Considerations ...

Teva Recalls Fentanyl Lots Over Product Insert

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Teva Pharmaceuticals recalls 13 lots of various strengths of fentanyl buccal tablets due to safety updates that were omitted in th...

FDA Approves Otsuka/Lundbeck Schizophrenia Drug

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FDA approves an Otsuka America Pharmaceutical and Lundbeck NDA for Abilify Asimtufii (aripiprazole) a once-every-two-months inject...

ViiV Dovato Ad Claims Challenged

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The Better Business Bureaus National Advertising Division refers to FDA and the Federal Trade Commission for review and possible e...

Drug Supply Chain Independence Bill

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Bipartisan legislation is reintroduced in the House that its sponsors say will make the nations pharmaceutical supply chain less d...

Ultromics Gets Breakthrough Status for AI Device

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FDA grants Ultromics a breakthrough device designation for its artificial intelligence-supported platform for detecting cardiac am...

Cybersecurity Alert on Illumina Device Software

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FDA issues an alert about a cybersecurity vulnerability affecting the Universal Copy Service software in several Illumina laborato...

FDA Approves Oral Fecal Microbiota Capsules

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FDA approves a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), an orally administered microbiota-based prod...

Prevent Makena Compounding: Public Citizen

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Public Citizen calls on FDA to promptly add Covis Pharmas Makena to the official list of drugs that have been withdrawn for reason...

Info Collection on Animal Drug Reporting

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Federal Register notice: FDA sends to OMB an information collection entitled Records and Reports Concerning Experiences with Appro...