Federal Register Notice: FDA announces a 4/6/2017 public meeting on Patient-Focused Drug Development for Sarcopenia.
FDA approves an Anacor Pharmaceuticals NDA for Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two yea...
Stakeholders urge major revisions to an FDA draft guidance on software as a medical device that incorporates an International Medical Device Regulator...
CDRHs Malvina Eydelman says a new FDA Web-based LASIK questionnaire can be used to assess patients before and after surgery.
Hogan Lovells attorneys summarize 21st Century Cures provisions relating to regulation of drugs and biologics.
FDA says it is requiring Warnings on labels of general anesthetics and sedation drugs about the risk of childrens brain development when used in child...
Attorney James Beck says that preemption of state law failure-to-warn claims applies to OTC drugs in many instances, in the same way as it applies to ...
CDERs Office of Prescription Drug Promotion says a Sanofi TV ad for Toujeo makes false or misleading representations about the drugs risks.