FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP, Other Violations at American Family Pharmacy

[ Price : $8.95]

FDAs Detroit District Office warns American Family Pharmacy about CGMP and misbranding violations.

Generics Saved U.S. $254 Billion Last Year

[ Price : $8.95]

A new report finds that the U.S. health care system saved a record $254 billion in 2014 from generic drugs.

Shorter Drug R&D Times Yield Market Exclusivity

[ Price : $8.95]

A Tufts Center for the Study of Drug Development analysis shows that marketing exclusivity often goes to the company that can shor...

CDER Posts Policy on NDA Classification Codes

[ Price : $8.95]

A new CDER policy document describes the NDA classification code the Center assigns to a submission based on product characteristi...

Guidance on Developing HIV-1 Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Tr...

GSK, Merck Team Up on Combo Trial Against Tumors

[ Price : $8.95]

GlaxoSmithKline and Merck begin a Phase 1 clinical trial designed to evaluate GSKs investigational immunotherapy GSK3174998 as a m...

FDA Approves INVO Bio Vaginal Fertility Incubator

[ Price : $8.95]

FDA approves an INVO Bioscience de novo petition to allow the marketing of the INVOcell, an intravaginal culture system for use in...

Novartis Settlement Shows Focus on PBMs

[ Price : $8.95]

Attorneys say a recent Novartis settlement of civil kickback claims demonstrates the Justice Departments enforcement focus on phar...

Court Should Retreat from Wyeth Decision: Troy

[ Price : $8.95]

Former FDAer Daniel Troy calls on the Supreme Court to back away from its Wyeth v Levine decision and allow much more preemption o...

Expedited Pathway Granted to Wearable Artificial Kidney

[ Price : $8.95]

FDA grants an Expedited Access Pathway designation for the first Wearable Artificial Kidney which was invented by UCLA/Cedars Sina...