FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Covid-19 Actemra REMS Guidance

[ Price : $8.95]

FDA issues a guidance modifying REMS requirements for Genentechs Actemra under certain conditions during the Covid-19-related Acte...

FDA Approves 2 Svelte Stent Systems

[ Price : $8.95]

FDA approves two Svelte Medical drug-eluting stent systems.

Draft Guide on Bowel Cleansing Products

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Consid...

Pediatric Anti-infective Drug Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatr...

Impurities Guide on Residual Solvents

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Sol...

House Report Slams Drug Pricing, Patent Manipulating

[ Price : $8.95]

A U.S. House Oversight and Reform Committee staff report alleges troubling issues with drug companies rising prices and actions to...

Urotronic PMA Approved for Urethral Strictures

[ Price : $8.95]

FDA approves an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures.

FDA Panel Knocks Down Ischemic Stroke Device

[ Price : $8.95]

An FDA advisory committee votes 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate that the devices b...

Draft Guide on Rhinosinusitis Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs ...

Merck HIV Drug Trials on Clinical Hold

[ Price : $8.95]

FDA places clinical holds on Merck INDs for islatravir for HIV-1 pre-exposure prophylaxis due to decreases in total lymphocyte and...