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Pharmacists Planning Service asks FDA to issue a regulation placing Chantix behind the pharmacy counter.[ Price : $8.95]
FDA posts a draft guidance on Electronic Submission of Lot Distribution Reports.[ Price : $8.95]
Amgen submits a BLA for evolocumab seeking approval for treating high cholesterol.[ Price : $8.95]
PhRMA calls on FDA to use notice-and-comment rulemaking for new regulations about communicating new information about both drug ri...[ Price : $8.95]
FDA lifts a partial clinical hold against OncoMed Pharmaceuticals and enrollment in its vantictumab (anti-Fzd7, OMP-18R5) Phase 1 ...[ Price : $8.95]
Takeda says a 10-year epidemiology study has shown no overall statistically significant increased risk of bladder cancer in patien...[ Price : $8.95]
CDER issues a MAPP with priorities and time periods for posting drug approval information on the Centers Web site.[ Price : $8.95]
Pfizer asks FDA to set specific early exposure BE criteria for drug products referencing its ADHD drug Quillivant XR.