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 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...

Remote Medication System into Class 2

[ Price : $8.95]

Federal Register Final rule: FDA classifies the remote medication management systems into Class 2 with a guidance serving as the s...

Guidance on Mechanical Calibration CGMPs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on the current good manufacturing practices for the use of mechanical calib...

FDA Approves Humate-P Storage Conditions Change

[ Price : $8.95]

FDA has approved new storage conditions for CSL Behrings Humate-P that remove refrigeration requirements.

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.

Science Board Meeting Date Changed

[ Price : $8.95]

Federal Register Notice: FDA changes the date of the meeting of the Science Board to the FDA to 12/3.