CDER director Janet Woodcock says she is not too concerned with an Administration change next month, saying that for now it is business as usual and t...
Washington Legal Foundation asks the California Supreme Court to reject a theory of innovator liability a lower state court used to permit plaintiffs ...
FDA names deputy associate commissioner for regulatory affairs Steven M. Solomon, DVM, as the new Center for Veterinary Medicine director.
Federal Register Notice: FDA and HHSs Office for Human Research Protections make available a guidance entitled Use of Electronic Informed Consent Que...
Osmotica asks FDA to require in vivo ANDA bioequivalence testing for the 225 mg strength of its venlafaxine HCl.
FDA extends until 4/10/2017 the comment period on its initiative to review Manufacturer Communications Regarding Unapproved Uses of Approved or Cleare...
Retiring Office of New Drugs director John Jenkins says CDER is issuing more complete response letters this year, and it is significantly reducing the...
FDA and HHS Office for Human Research Protections release a guidance on Use of Electronic Informed Consent (eIC) Questions and Answers.