FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Approves Genmab Supplemental BLA for Arzerra

[ Price : $8.95]

FDA approves a Genmab supplemental BLA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide fo...

Court Dismisses Amiodarone Suit Against Sandoz

[ Price : $8.95]

An Alabama federal court approves a Sandoz motion to dismiss claims against it alleging improper warnings about the risks of amiod...

Draft Guidance Allows Limited Generic Label Changes

[ Price : $8.95]

Attorney Bradley Davidsen says a new FDA draft guidance on safety updates to some generic drug labels raises hope that the agency ...

FDA Plans November Hearing on Off-label Communications

[ Price : $8.95]

FDA plans a two-day public hearing in November to obtain input on off-label communication by drug and medical device companies.

Regulations Prevent Petition Response: FDA

[ Price : $8.95]

FDA denies a petition asking it to place a clinical hold on an extracorporeal liver assist device reportedly being developed by Vi...

FDA Requires Warning of Opioid/Benzodiazepine Risks

[ Price : $8.95]

FDA requires labeling changes to many opioids and benzodiazepines warning about adverse risks of using them together.

Guidance on Cigar Warning Plans

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Submission of Warning Plans for Cigars.

Guidance on Reducing Zika Transmission by Blood/Blood Components

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Bloo...

FDA Amends Drug Registration/Listing Regulations

[ Price : $8.95]

Federal Register Final rule: FDA amends its regulations on drug establishment registration and drug listing for finished drug prod...

FDA Clears Siemens Somatom Drive CT System

[ Price : $8.95]

FDA clears a Siemens 510(k) for the Somatom Drive computed tomography system, a new dual source scanner designed to deliver more p...