FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Updates Safety Alert on Endovascular Graft Systems

[ Price : $8.95]

FDA updates its 2019 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms...

Guidance on Combination Product Feedback

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.

Ensemble Orthopedics CMC Osteoarthritis Implant Cleared

[ Price : $8.95]

FDA clears an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of th...

Labeling Changes for Merck Diabetes Drugs

[ Price : $8.95]

FDA approves labeling changes on Mercks Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (...

Notice on Complex Generic Meetings Guidance Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects an 11/25 notice on a guidance entitled Formal Meetings Between the Food and Drug Administrat...

Comments on Bladder Cancer Drug Development Guidance

[ Price : $8.95]

Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.

Genus Seeks Court Order Against Lannetts Numbrino

[ Price : $8.95]

Genus asks a Maryland federal court to require FDA to withdraw its approval of Lannett Numbrino because Lannett made materially un...

Kessler, Sharfstein in the Running for FDA Top Post

[ Price : $8.95]

FDA watchers speculate that former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein are top c...

FDA Renews Pharmacy Compounding Advisory Panel

[ Price : $8.95]

Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.

Groups Ask Agency, Research Funding

[ Price : $8.95]

Some 76 healthcare organizations call on congressional leaders to approve increased funding for FDA and other key health agencies ...