FDA warns Ahmedabad, India-based Champaklal Maganlal Homeo Pharmacy about CGMP violations in its manufacturing of over-the-counter and homeopathic dru...
Pharmaceutical Research and Manufacturers of America suggests the International Council for Harmonization make changes to its M13A draft guidance on b...
The directors of the CDER Office of Translational Sciences and Office of Communications explain their joint pilot program for guidance snapshots and p...
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.
