FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Nanchang Anobri FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 with 12 observations from a 2023 inspection at Chinas Nanchang Anobri drug manufacturing facility.

IDE OKd for Robotic Prostate Cancer Surgery

[ Price : $8.95]

FDA approves a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with...

Zealand Hypoglycemia NDA Denied FDA Approval

[ Price : $8.95]

FDA issues Zealand Pharma a complete response letter on its NDA for dasiglucagon and its use in preventing and treating hypoglycem...

Bayer Files NDA for Menopause Drug

[ Price : $8.95]

FDA accepts a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe hot flashes asso...

FDA Exempts Some from Supply Chain Security Act

[ Price : $8.95]

FDA grants exemptions to Drug Supply Chain Security Act eligible connected trading partners, pushing the implementation date for e...

GSK Says Arexvy Protects Over Three RSV Seasons

[ Price : $8.95]

GSK says trial data show its Arexvy protects through three complete RSV seasons.

6 Baxter Products in Shortage Due to Hurricane: FDA

[ Price : $8.95]

FDA says six products manufactured at Baxters hurricane-damaged facility in North Carolina are now on the shortage list.

Do More to Prevent DSCSA Disruptions: Congress

[ Price : $8.95]

Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act...

Neuvivo Files NDA for Lou Gehrigs Therapy

[ Price : $8.95]

Neuvivo files an NDA for NP001 (sodium chlorite infusion) for treating amyotrophic lateral sclerosis (also known as Lou Gehrigs di...

FDA New Alternative Methods Office Needed: Report

[ Price : $8.95]

An FDA Science Advisory Board subcommittee calls on the agency to create a centralized office to coordinate work on New Alternativ...