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CDER director Janet Woodcock says she is not too concerned with an Administration change next month, saying that for now it is bus...[ Price : $8.95]
Washington Legal Foundation asks the California Supreme Court to reject a theory of innovator liability a lower state court used t...[ Price : $8.95]
FDA names deputy associate commissioner for regulatory affairs Steven M. Solomon, DVM, as the new Center for Veterinary Medicine d...[ Price : $8.95]
Federal Register Notice: FDA and HHSs Office for Human Research Protections make available a guidance entitled Use of Electronic I...[ Price : $8.95]
Osmotica asks FDA to require in vivo ANDA bioequivalence testing for the 225 mg strength of its venlafaxine HCl.[ Price : $8.95]
FDA extends until 4/10/2017 the comment period on its initiative to review Manufacturer Communications Regarding Unapproved Uses o...[ Price : $8.95]
Retiring Office of New Drugs director John Jenkins says CDER is issuing more complete response letters this year, and it is signif...[ Price : $8.95]
FDA and HHS Office for Human Research Protections release a guidance on Use of Electronic Informed Consent (eIC) Questions and An...