[ Price : $8.95]
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 ...[ Price : $8.95]
FDAs San Francisco District Office warns Innovative Compounding Pharmacy about CGMP violations in its compounding of unapproved do...[ Price : $8.95]
CDER researchers say that links to disease awareness Web sites from branded prescription drug sites may lead to confusion and misp...[ Price : $8.95]
Mylan files a BLA for MYL-1401O, a proposed biosimilar copy of trastuzumab (Genentechs Herceptin), indicated to treat certain HER2...[ Price : $8.95]
FDA accepts an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell dis...[ Price : $8.95]
Two professors say FDA should use a partial-approval system for drugs rather than the currently all-or-nothing approach.[ Price : $8.95]
House Energy and Commerce Committee members Diana DeGette (D-CO) and Susan Brooks (R-IN) ask FDA for information about how it is w...[ Price : $8.95]
FDA hires former Merck executive Peter Stein to serve as CDER Office of New Drugs deputy director effective 11/14.