Federal Register notice: FDA makes available a draft guidance entitled Special Considerations, Incentives, and Programs to Support the Approval of New...
FDA says there are deficiencies in the Tricida NDA for its veverimir to treat metabolic acidosis in patients with chronic kidney disease.
Attorney Mark Schwartz outlines three possible scenarios to resolve the current pause in FDA foreign manufacturing facility inspections.
FDA is giving priority review to a Merck/Bayer NDA for vericiguat to treat some chronic heart failure patients.
Federal Register notice: FDA makes available a draft guidance on using data from foreign investigational studies in new animal drug applications.
A CDRH Webinar discusses methods for decontaminating N95 masks for re-use and agency guidance on decontamination.
Hogan Lovells attorneys say FDA authority to approve biosimilars under the BPCIA could end if the Supreme Court throws out the Affordable Care Act and...
An FDA advisory committee provides a mixed vote (8 to 7) in favor of approval for Mallinckrodts terlipressin and its use to treat adults with hepatore...