Federal Register notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents.
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing that the drug produc...
Federal Register notice: FDA makes available a draft guidance entitled Insanitary Conditions at Compounding Facilities.
Federal Register notice: FDA makes available a final guidance entitled Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities....
Federal Register notice: FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2019 $...
FDA asks pen needle manufacturers to add a label Warning regarding proper use of the devices.
FDA releases the FDA-483 with two observations from a September inspection at the Sun Pharmaceutical facility in Punjab, India.
FDA releases the FDA-483 with three observations from an inspection at Indias Stride Pharma Science.