FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Allergan Expanded Use Cleared for CoolSculpting

[ Price : $8.95]

FDA clears an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline...

FDA OKs Genentechs Hemlibra for Some Hep A

[ Price : $8.95]

FDA approves Genentechs Hemlibra for a new prophylaxis indication for hemophilia A in patients without factor VIII inhibitors.

Withdraw Drug Dissolution Guidances: Researcher

[ Price : $8.95]

A citizen petition asks FDA to withdraw drug dissolution guidances and the dissolution database because dissolution testers have n...

Consider DaVinci Cautery Instrument Ban: Petition

[ Price : $8.95]

Unplug the Robot activist Jennifer Nelson asks FDA to consider banning and recalling all DaVinci Robot permanent cautery instrumen...

Guide on Drug Packaging and Labeling Terms

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Selection of the Appropriate Package Type Terms and Recomme...

Draft Guide on ANDA Blocking Petitions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Citizen Petitions and Petitions for Stay of Action Subject ...

CDRH Plans 21 Guidances This Year

[ Price : $8.95]

CDRH issues a list of 21 final and draft gudiances it expects to publish in FY 2019.

Glaxo Resuming Some Doctor Payments

[ Price : $8.95]

GlaxoSmithKline reverses a 2013 policy and will pay some doctors for promoting some of its drugs.

FDA Clears CarboFix Carbon Fiber Connectors

[ Price : $8.95]

FDA clears a CarboFix in Orthopedics 510(k) for the CarboClear Carbon Fiber Transverse Connectors to be used in conjunction with i...

Liveyon Recalls Stem Cell Product

[ Price : $8.95]

Liveyon recalls all ReGen Series stem cells due to reported adverse reactions.