FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Genentech Backs More Biosimilar Label Transparency

[ Price : $8.95]

Genentech joins AbbVie in calling on FDA to provide enhanced transparency in biosimilar labeling through a unique approach rather ...

Few Suggestions for FDA Migraine Drug Guidance

[ Price : $8.95]

Drug companies recommend some changes to a draft FDA guidance on developing drugs for acute migraine treatment.

Comments Sought on Small Business Device Fee Forms

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on Forms FDA 3602 and 3602A, which will allow applicants to certify that they qualify ...

Comments Sought on Tobacco Regulation, Marketing

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on agency meetings with tobacco manufacturers, etc. on their plans to research the reg...

Comments Sought on Notification for GRAS Substances

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on: Substances Generally Recognized as Safe: Notification Procedure 21 CFR 170.36 and...

Panel to Discuss Pediatric Development for Cancer Drugs

[ Price : $8.95]

Federal Register FDAs Pediatric Oncology Subcommittee will meet 11/19 to discuss potential pediatric development plans for two pro...

PhRMA Strongly Supports PDUFA

[ Price : $8.95]

PhRMA voices support for PDUFA and changes it wants in PDUFA 6.

Opioid Epidemic Study Results Sought

[ Price : $8.95]

36 advocacy groups ask the Senate Finance Committee to release results of a probe into the connection between drug companies and g...

NORD 2011 Petition Granted, Denied in Part

[ Price : $8.95]

FDA grants in part and denies in part a National Organization for Rare Disorders petition seeking acknowledgment of special circum...

CDER Data Standards MAPP

[ Price : $8.95]

CDER issues a policies and procedures manual on its data standards program.