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Human Drugs

Researchers Develop MRI-Friendly Protein Micelle

New York University researchers say they have developed nanoscale protein micelles that can both deliver drug therapy and be tracked by MRI.

Medical Devices

NEST Real-World Evidence Activities Updated

CDRH director Jeffrey Shuren updates work of the National Evaluation System for health Technology in assessing how real-world evidence can be used to ...

Medical Devices

Siemens Mobilett X-ray System Cleared

FDA clears a Siemens Healthineers 510(k) for the Mobilett Elara Max mobile X-ray system, which features improved information technology security as we...

Human Drugs

FDA OKs Losartan with NMBA Below 9.82 PPM

FDA says it is allowing temporary distribution of losartan with NMBA levels up to 9.82 ppm to ease a supply shortage.

Human Drugs

Amphastar ANDA Approved for Generic Lovenox Vials

FDA approves an Amphastar Pharmaceuticals ANDA for blood thinner enoxaparin sodium injection 300mg/3mL (100mg/mL) multiple dose vials, a generic copy ...

Federal Register

Guide on Pre-Exposure HIV Drug Development

Federal Register notice: FDA makes available a final guidance entitled Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for...

Human Drugs

J&J Agrees to End Forced Swim Tests

PETA says Johnson & Johnson has agreed to stop so-called forced swim tests of small animals as a means of determining effectiveness of drugs to treat ...

Human Drugs

CDER Top Drug Compounding Official Leaving Agency

CDER senior science advisor for compounding Julie Dohm resigns to join Covington & Burling, effective 3/29.

Medical Devices

FDA Warns 2 Breast Implant Makers on Studies

FDA warns two breast implant manufacturers about deficiencies in their mandated post-approval studies of device long-term safety and risks.

Human Drugs

Partial Hold on Abbvie/Roche Myeloma Trial

FDA places a partial clinical hold on an AbbVie and Roche clinical trial program for Venclexta/Venclyxto (venetoclax) for the investigational treatmen...