FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Group Wants Chantix Behind Pharmacy Counter

[ Price : $8.95]

Pharmacists Planning Service asks FDA to issue a regulation placing Chantix behind the pharmacy counter.

FDA Posts Draft Guide on BLA Lot Distribution eSubmissions

[ Price : $8.95]

FDA posts a draft guidance on Electronic Submission of Lot Distribution Reports.

Amgen BLA Submitted for High Cholesterol Therapy

[ Price : $8.95]

Amgen submits a BLA for evolocumab seeking approval for treating high cholesterol.

PhRMA Wants Risk, Efficacy Info Treated the Same

[ Price : $8.95]

PhRMA calls on FDA to use notice-and-comment rulemaking for new regulations about communicating new information about both drug ri...

FDA Lifts Clinical Hold on OncoMed Cancer Therapy

[ Price : $8.95]

FDA lifts a partial clinical hold against OncoMed Pharmaceuticals and enrollment in its vantictumab (anti-Fzd7, OMP-18R5) Phase 1 ...

Study Finds No Increased Bladder Cancer Risk for Pioglitazone

[ Price : $8.95]

Takeda says a 10-year epidemiology study has shown no overall statistically significant increased risk of bladder cancer in patien...

MAPP on Communicating Drug Approvals

[ Price : $8.95]

CDER issues a MAPP with priorities and time periods for posting drug approval information on the Centers Web site.

Pfizer Wants Early Exposure BE Test for Generic Quillivant

[ Price : $8.95]

Pfizer asks FDA to set specific early exposure BE criteria for drug products referencing its ADHD drug Quillivant XR.

Guidance on Blood Donor Screening for Syphilis

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on recommendations for screening, testing, and management of blood donors and blo...

ICH Guidance on Veterinary Electronic Document Exchange

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Electronic Exchange of Documents: File Format Recommendations (VICH GL53) ...