FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews

[ Price : $8.95]

FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...

Senator Seeks FDA Records on Covid Vaccine Safety Review

[ Price : $8.95]

Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from...

Committee Backs Moderna Flu Vaccine

[ Price : $8.95]

The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.

FDA Wants Testosterone Therapy Labels Updated

[ Price : $8.95]

HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical ...

Review Memo Dismisses Hoegs Block on Tzield Approval

[ Price : $8.95]

FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi su...

Grace Therapeutics Preparing NDA Resubmission

[ Price : $8.95]

Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.

FDA Updates Device READI-Home Innovation Challenge Initiative

[ Price : $8.95]

FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate developme...

Leadership Changes Affect FDA Priorities: Mintz Post

[ Price : $8.95]

Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignati...

Petition Urges FDA to Restrict Antibiotic Use in Animals

[ Price : $8.95]

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals fo...

Evaluate Generic Bicalutamide Manufacturers: Petition

[ Price : $8.95]

A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient s...