FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Info on DTC Ad Brief Summaries Approved by OMB

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on experimental evaluation of br...

Comments Extended on Electronic Package Insert

[ Price : $8.95]

Federal Register Notice: FDA reopens until 12/6 the comment period on the electronic distribution of FDA-approved prescribing info...

FDA Orphan Status for TB Drug

[ Price : $8.95]

FDA grants a Sequella orphan drug status request for SQ109, an investigational drug for treating tuberculosis.

FDA OKs Genzymes Renagel Successor

[ Price : $8.95]

FDA approves a Genzyme Corp. sNDA for Renvela (sevelamer carbonate), indicated for controlling serum phosphorus in patients with c...

FDA Says Telavancin Approvable

[ Price : $8.95]

FDA says Theravances once-daily injectable antibiotic telavancin is approvable with conditions.

Merck Hopes 3rd Time is a Charm for OTC Mevacor

[ Price : $8.95]

Merck heads back to an advisory panel in December to seek support a third time for an over-the-counter version of cholesterol-lowe...

Advisors Say Cold Drugs Not for Children Under 6

[ Price : $8.95]

FDA advisors say OTC cough and cold products should not be used in children under age 6.

FDA Says DORs orBec Not Approvable

[ Price : $8.95]

FDA issues a not approvable letter to DOR BioPharma on its NDA for orBec (oral beclomethasone dipropionate), indicated for treatin...

CDER Receives ANDAs for Generic Zymar and Tarka

[ Price : $8.95]

CDER says it has received the first ANDAs with Paragraph 4 certifications for generic copies of Allergans Zymar and Abbotts Tarka....

Info on Trials for Serious Diseases Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on clinical trials for serious or life-threatening disea...