FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

IND Co-development Specifics Sought

[ Price : $8.95]

Three groups make suggestions for FDA to consider in writing a guidance on co-developing investigational drugs.

FDA Begins Actos Safety Review

[ Price : $8.95]

FDA says it has begun a safety review of Takeda's diabetes drug Actos (pioglitazone) due to potential bladder risks.

FDA Corrects Small Error in Inhaler Rule

[ Price : $8.95]

Federal Register Final rule: FDA corrects a small error in a 4/14 final rule on removing essential-use designations for certain su...

Comments Sought on FDA, CMS Overlapping Reviews

[ Price : $8.95]

Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services seek comments on what products would be appropriat...

Hill Asks J&J Execs to Testify on Childrens Drug Recalls

[ Price : $8.95]

The House Oversight and Government Reform Committee asks two Johnson & Johnson executives to clarify information on the companys r...

FDA Needs a Global Regulatory Alliance

[ Price : $8.95]

CDER compliance director Deborah Autor says a worldwide alliance of drug regulators is needed because no country can keep up with ...

Tobacco Panel to Discuss Menthol Cigarettes Impact

[ Price : $8.95]

Federal Register Notice: FDAs Tobacco Products Scientific Advisory Committee will meet 10/7 on industry documents on the use of me...

Reviewers Back Higher Pradaxa Dose

[ Price : $8.95]

FDA asks its Cardiovascular and Renal Drugs Advisory Committee to comment on the safety, effectiveness, and risk/benefit of Boehri...

FDA, CMS Considering Parallel Review Process

[ Price : $8.95]

FDA and CMS are soliciting comments on a proposal for voluntary parallel review of innovative medical products as a way of speedin...

Grant for Study on Alpha 1 Antitrypsin Deficiency Therapy

[ Price : $8.95]

Applied Genetic Technologies wins a $1 million grant from FDA' orphan products program to fund a Phase 2 clinical trial intended t...