Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.
The Colorado Society of Addiction Medicine says the labeling for buprenorphine products to treat opioid use disorder should be changed to recognize th...
Philips sends FDA additional comments on the agency discussion paper on strengthening cybersecurity practices for servicing medical devices.
Federal Register notice: FDA seeks comments on an information collection extension entitled Patent Term Restoration; Due Diligence Petitions; Filing, ...
Federal Register notice: FDA makes available a publication entitled Modifications to the List of Recognized Standards, Recognition List Number: 058....
FDA says it will temporarily allow distribution of some sitagliptin products with the nitrosamine impurity NTTP above acceptable intake levels to avoi...
Five stakeholders comment on an FDA draft guidance on radiolabeled mass balance studies.
FDA clears ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube in three sizes.
