FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Issues Form-483 to Alkem Labs in India

[ Price : $8.95]

FDA issues Alkem Laboratories a three-item Form-483 after an inspection recently concluded at the firms Ankleshwar, India active p...

Clarifications Sought in Advisors Conflict Guidance

[ Price : $8.95]

Advocacy groups raise issues with a draft FDA guidance on evaluating appearance issues with advisory committee members.

Cures Act Medical Device Implications Explained

[ Price : $8.95]

Three Akin Gump attorneys review 21st Century Cures provisions affecting medical devices.

FDA Updates Actos Bladder Cancer Risk

[ Price : $8.95]

FDA says it has approved updated labeling for drugs containing pioglitazone covering additional studies showing a potentially incr...

FDA Guide on Identifying Suspect Drug Supply

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance on Drug Supply Chain Security Act Implementation: Identification of Suspec...

Ex-Pharma Execs Arrested in Racketeering Scheme

[ Price : $8.95]

Feds arrest several former pharmaceutical executives and managers at Insys Therapeutics on charges that they led a nationwide cons...

ProNova Gains FDA Clearance for Proton Therapy

[ Price : $8.95]

ProNova Solutions receives FDA 510(k) clearance for its SC360 proton therapy system, a compact 360-degree pencil beam scanning pro...

Docket Opened for Drug Review Assessment Under PDUFA

[ Price : $8.95]

Federal Register Notice: FDA creates a docket to obtain comments on the final assessment of the Program for Enhanced Review Transp...

FDA Denies Petition Seeking Optimal Naloxone Dose

[ Price : $8.95]

FDA denies a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, asking that it publish a guidance for...

FDA Accepts AstraZeneca BLA for Bladder Cancer Therapy

[ Price : $8.95]

FDA accepts for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with lo...