FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Quality Violations at Huhui OTC Facility

[ Price : $8.95]

FDA warns Shanghai Huhui Daily Use Chemical Products Company of CGMP and other violations at its Shanghai, China, manufacturing fa...

FDA Grants Restriction on Lyrica ANDAs

[ Price : $8.95]

FDA grants a Pfizer request involving Lyrica ANDAs and denies two other requests.

Growing Interest for Breakthrough Drug Designations: Woodcock

[ Price : $8.95]

CDER director Janet Woodcock says her Center is seeing growing interest from pharmaceutical developers in taking advantage of a ne...

Zofran 32 mg IV Dose Being Pulled from Market

[ Price : $8.95]

FDA says it is working with manufacturers to recall the single 32 mg IV dose of Zofran due to the potential risk of serious cardia...

Q&A Guidance on FDA Oversight of Pet Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, FDA Oversight of PET Drug Products Questions and Answers.

Info Corrected on Preoperative Skin Prep Products Hearing

[ Price : $8.95]

Federal Register Notice: FDA corrects a 11/21 notice on antiseptic patient preoperative skin preparation products.

Participants Sought to Select Device GMP Panelists

[ Price : $8.95]

Federal Register Notice: FDA seeks participants to select nonvoting industry representatives to serve on CDRHs Device Good Manufac...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Avis Dairy, Casmed, New Star Lasers, Shanghai Ruike Sports, Shanghai Huhui Daily...

FDA Sets July Review Target for Astellas NDA

[ Price : $8.95]

FDA accepts for review an Astellas Pharma U.S. NDA for tacrolimus extended-release capsules for preventing organ rejection in adul...

Are Antibiotic Trial Requirements Too Tough?

[ Price : $8.95]

Observers of the antibiotic market question whether FDA is really changing its approval requirements for clinical trials that they...