FDA says a final rule taking effect 1/9/17 aims to prevent late citizen petitions or petitions for a stay of action from delaying approval of a generi...
FDAs San Francisco District Office warns Innovative Compounding Pharmacy about CGMP violations in its compounding of unapproved domperidone products f...
CDER researchers say that links to disease awareness Web sites from branded prescription drug sites may lead to confusion and misperceptions about the...
Mylan files a BLA for MYL-1401O, a proposed biosimilar copy of trastuzumab (Genentechs Herceptin), indicated to treat certain HER2-positive breast and...
FDA accepts an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell disease.
Two professors say FDA should use a partial-approval system for drugs rather than the currently all-or-nothing approach.
House Energy and Commerce Committee members Diana DeGette (D-CO) and Susan Brooks (R-IN) ask FDA for information about how it is working to address po...
FDA hires former Merck executive Peter Stein to serve as CDER Office of New Drugs deputy director effective 11/14.