FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Medical Foods Q&A Guidance

[ Price : $8.95]

FDA publishes an updated question-and-answer guidance on the definition and regulation of medical foods.

Drug Supply Guide on Illegitimate/Suspect Products

[ Price : $8.95]

Federal Register notice: FDA posts a final guidance entitled Definitions of Suspect Product and Illegitimate Product for Verificat...

Local Anesthetic Duration Drug Guidance

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance with information for sponsors who are developing certain local anesthetic drug...

Guide on Literature-Based Animal Drug Approvals

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled The Use of Published Literature in Support of New Animal Dr...

Telix sNDA Approved for Illuccix Selection

[ Price : $8.95]

FDA approves a Telix Pharmaceuticals supplemental NDA for Illuccix and its use in selecting prostate cancer patients for whom Nova...

FDA Clears BD Vaginitis Test

[ Price : $8.95]

FDA clears the BD Vaginal Panel running on the BD COR System to detect the three most common causes of vaginitis.

Glaxo MenABCWY Vaccine Hits 11 Endpoints

[ Price : $8.95]

GlaxoSmithKline says its meningococcal MenABCWY vaccine candidate met all 11 primary endpoints in a pivotal Phase 3 trial.

IPRP Cell/Gene Therapy Raw Materials Paper

[ Price : $8.95]

FDA publishes an International Pharmaceutical Regulators Program reflection paper addressing general considerations for using raw ...

Senate Appropriators Announce 4/19 FDA Budget Hearing

[ Price : $8.95]

The Senate Appropriations Committee announces a 4/19 subcommittee hearing to review FDAs fiscal year 2024 budget request.

Panel Votes to Support Paxlovid NDA Approval

[ Price : $8.95]

An FDA Advisory Committee votes 16 to 1 that Pfizers Paxlovid (nirmatrelvir and ritonavir) has a favorable benefit-risk profile fo...