American Council on Science and Health

The Black Box: The FDA’s strongest warning is a work in progress

Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and ...
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.
Medindia

Blood Pressure Drug Ziac Recalled Over Possible Contamination

The FDA has recalled thousands of Ziac blood pressure tablets after traces of a cholesterol drug were found during testing, ...
The New York Times

U.S. Announces Negotiated Prices for 15 Drugs Under Medicare

The Trump administration said that had the new prices been in effect last year, Medicare would have saved $12 billion, which would have reduced its spending on those drugs by 44 percent. By Rebecca ...