FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Drug Inspections Target Quality Units

[ Price : $8.95]

A Regulatory Affairs Professionals Society enforcement session discusses FDA drug inspections that appear to be paying closer atte...

FDA Approves REMS for Nuvigil/Provigil

[ Price : $8.95]

FDA approves a Risk Evaluation and Mitigation Strategies for Cephalon's Nuvigil (armodafinil) tablets and Provigil (modafinil) tab...

FDA Guidance on Drug Development Tool Qualification

[ Price : $8.95]

A new FDA guidance describes the qualification process for drug development tools, such as biomarkers and patient-reported outcome...

Guidance on Qualifying Drug Development Tools

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on the qualification process for drug development tools.

FDA Warns on Teething Tablets

[ Price : $8.95]

FDA warns consumers that Hyland Teething Tablets may contain inconsistent amounts of belladonna, which can cause serious harm at l...

CBER Lab Receives National Accreditation

[ Price : $8.95]

CBERs Laboratory Quality System program gains national accreditation for13 testing methods recognized under the ISO/IEC 17025 stan...

FDA Approves Low-dose Warner Chilcott Contraceptive

[ Price : $8.95]

FDA approves a Warner Chilcott NDA for Lo Loestrin FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tabl...

Petition Wants FazaClo 200 mg Listed as RLD

[ Price : $8.95]

A citizen petition asks FDA to designate FazaClo 200 mg as the reference-listed drug for clozapine orally disintegrating tablets.

FDA Wants More Info on ViroPharmas Cinryze Manufacturing

[ Price : $8.95]

FDA asks ViroPharma for more information on its plans to expand Cinryze manufacturing to industrial-scale lots.

Panel to Discuss Products for Prostate Cancer Risk Reduction

[ Price : $8.95]

Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/1 to discuss the safety and efficacy of Avodart and ...