FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Panel to Hear Research Updates

[ Price : $8.95]

Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 1/14/16 to hear updates on the...

FDA Reviews Regulatory Issues for Gene Therapies

[ Price : $8.95]

FDA officials say clinical trial endpoints for investigational gene therapy products intended for treating cancer must be carefull...

Glades Drugs Recalls Compounded Multivitamins

[ Price : $8.95]

Glades Drugs recalls compounded multivitamin capsules containing high amounts of Vitamin D3 (cholecalciferol) after receiving seve...

FDA Approves BMS Enpliciti for Multiple Myeloma

[ Price : $8.95]

FDA approves a Bristol-Myers Squibb NDA for Empliciti (elotuzumab) for use in combination with two other therapies to treat multip...

Petition Denied Seeking Stricter Bioequivalence for Naprelan

[ Price : $8.95]

FDA denies an Almatica Pharma petition asking the agency to impose specific bioequivalence requirements on any ANDAs that referenc...

Complete Response on BMS Opdivo sBLA

[ Price : $8.95]

FDA sends Bristol-Myers Squibb a complete response letter, declining to approve a supplemental BLA for Opdivo (nivolumab) as a sin...

FDA Clears Siemens Robotic X-ray System

[ Price : $8.95]

FDA clears a Siemens Healthcare 510(k) for the Multitom Rax (Robotic Advanced X-ray), a universal diagnostic imaging system intend...

Panel to Discuss NDA/sNDA for Major Depressive Disorder

[ Price : $8.95]

Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 2/3/16 to discuss cognitive dysfunction in ma...

Comments Sought on Tobacco-Derived Products

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on products made or derived from tobacco that will be subject to regulatio...

Boston Scientific Class 1 Recall of Rotawire Guidewire

[ Price : $8.95]

Boston Scientific begins a Class 1 recall of its RotaWire Elite Guidewire and wireClip Torquer Guidewire components because they m...