Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program; Controlled Correspondence.
Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Reports of Corrections and Removals 21 CF...
Federal Register notice: FDA seeks comments on an information collection revision entitled Investigational New Drug Application Requirements.
FDA commissioner Robert Califf says FDA and other agencies need new authorities to better combat the health misinformation that he says is partly resp...
Two Sheppard Mullin attorneys explain the provisions and impact of new FDA medical device cybersecurity requirements.
An SC Media online post says many medical device companies arent ready for new FDA cybersecurity safeguards.
FDA announces a new voluntary Radiation Sterilization Master File Pilot Program for medical devices that is open to nine companies.
CDRH director Jeff Shuren tells an American Enterprise Institute panel that new regulatory reforms from Congress will be needed for FDA and industry t...
