FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA OKs AquaBounty NADA for Salmon

[ Price : $8.95]

Federal Register Final rule: FDA approves an AquaBounty Technologies NADA for use of a rDNA gene construct in genetically engineer...

Guidance on Sunscreen Data to Support GRASE

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Nonprescription Sunscreen Drug Products Content and Format of Data Submissions ...

Guidance on Sunscreen Safety/Effectiveness Data

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Over-the-Counter Sunscreens: Safety and Effectiveness Data.

Prostate Documentation System into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the prostate lesion documentation system into Class 2.

Amag Pharma Responds to Makena Complete Response

[ Price : $8.95]

Amag Pharmaceuticals responds to an FDA complete response letter on its submission seeking approval for a new single-dose, preserv...

Angiodroid Withdraws 510(k) for Angiography CO2 Injector

[ Price : $8.95]

Angiodroid America withdraws a 510(k) submission for the Angiodroid CO2 Injector for Angiography because CO2 gas itself has not be...

Brief Seeks Supremes Review of State Label Change Rules

[ Price : $8.95]

Wiley Rein files an amicus brief with the U.S. Supreme Court on behalf of the U.S. Chamber of Commerce that asks the high court to...

FDA Approves BMS Opdivo for Kidney Cancer

[ Price : $8.95]

FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) to treat patients with advanced renal cell carcinoma in those who h...

FDA Approves Novartis Melanoma Drug Combination

[ Price : $8.95]

FDA grants regular approval to Novartis for its combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for treating patien...

Guidance on Sunscreen Active Ingredients

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.