FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Joint Advisory Panel to Review Pain Combo Drug

[ Price : $8.95]

Federal Register notice: FDA announces an 11/2 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and...

Committee Dems Hit Azar on LDT Approvals

[ Price : $8.95]

House Energy and Commerce Committee Democratic leaders blast HHS secretary Alex Azar for a grave error in pulling the review of la...

Eton Pharmaceuticals NDA for Liquid Topiramate

[ Price : $8.95]

Eton Pharmaceuticals files an NDA for topiramate oral solution as a monotherapy for treating certain seizures and preventing migra...

FDA Wins FOIA Ruling on Confidential Info Redactions

[ Price : $8.95]

FDA prevails in a Freedom of Information Act lawsuit that found the agency appropriately allowed company-directed redactions of co...

Vaccine Makers Could be Forced to be Transparent: Marks

[ Price : $8.95]

CBER director Peter Marks says that if vaccine manufacturers are not sufficiently transparent, FDA has procedures such as a commis...

FDA Wins Trump versus Science

[ Price : $8.95]

FDAs win in getting the White House to back down on its threats to block a controversial Covid-19 guidance illustrates a victory f...

Lilly Seeking Neutralizing Antibody Monotherapy EUA

[ Price : $8.95]

Lilly asks FDA for an EUA for a monoclonal antibody used in Covid-19 monotherapy.

FDA Chief Counsel on New Enforcement Precedent

[ Price : $8.95]

FDA chief counsel Stacy Cline Amin tells FDLI that the Covid-19 emergency has offered the agency an opportunity to set a new legal...

Include Premenopausal Women in Breast Cancer Trials: FDA

[ Price : $8.95]

FDA issues a draft guidance recommending the inclusion of premenopausal women in breast cancer drug clinical trials.

FDA Warns Battelle About Decontamination System MDR Issues

[ Price : $8.95]

FDA warns Battelle that the medical device reporting procedure and processes it has in place under an EUA for its respirator decon...