The Parenteral Drug Association recommends changes to an FDA guidance on remote interactive evaluations of drug manufacturing and bioresearch monitori...
FDA rejects a Pulse Biosciences 510(k) for an expanded indication to treat sebaceous hyperplasia with its cleared CellFX System.
Former CDRH orthopedic device medical officer Stephen Weber joins consultant group NDA Partners.
FDA warns health care providers and parents who receive enteral feeding that there is a risk of strangulation from using enteral feeding delivery sets...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conjugates.
The Justice Department says it collected more than $5.6 billion in settlements and judgments under the False Claims Act in FY 2021, with more than $5 ...
Federal Register notice: FDA classifies carbon dioxide gas-controlled tissue expanders into medical device Class 2 (special controls).
FDA clears an Ambu 510(k) for its Ambu aScope Gastro and Ambu aBox 2 display, the companys first sterile single-use gastroscope, which includes new ad...