Only 28 out of 64 medical device and diagnostic technologies, or 44 percent, requiring new Medicare coverage received reimbursement from 2016 to 2019, with the median time to at least…
Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of…
Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of…
The FDA and the European Medicines Agency (EMA) have both issued guidances on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals. Source: Drug…
An extended-release (ER) generic lamotrigine, used to treat epilepsy, is bioequivalent to GSK’s Lamictal, the FDA has determined — a finding that opens the way for pharmacy-level substitution of any…
CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry…
LXR Biotech received a warning letter from the FDA for having methods, facilities, controls for manufacturing, processing or holding its drug product that do not conform to GMPs, after the…
Quidel Cardiovascular’s recall of Quidel Triage Cardiac Panels, used to diagnose a heart attack, has been deemed class I by the FDA, the most serious type of recall as use…
The FDA slapped Iso-Tex with a Form 483 following a Jan. 30 – Feb. 10 inspection because the radiopharmaceutical manufacturer failed to prevent microbiological contamination of drug products at its…
Stryker received an FDA Form 483 after a Jan. 17-24 inspection of its Portage, Mo., plant showed that the company did not have a formal unit to receive, review and…