FDA Related News

Federal Register

Local Anesthetic Duration Drug Guidance

Federal Register notice: FDA posts a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce...

Federal Register

Guide on Literature-Based Animal Drug Approvals

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

Human Drugs

Telix sNDA Approved for Illuccix Selection

FDA approves a Telix Pharmaceuticals supplemental NDA for Illuccix and its use in selecting prostate cancer patients for whom Novartis Pluvicto is ind...

Medical Devices

FDA Clears BD Vaginitis Test

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

Biologics

Glaxo MenABCWY Vaccine Hits 11 Endpoints

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

Biologics

IPRP Cell/Gene Therapy Raw Materials Paper

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

FDA General

Senate Appropriators Announce 4/19 FDA Budget Hearing

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

Human Drugs

Panel Votes to Support Paxlovid NDA Approval

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

Human Drugs

Community Should Push AA Drug Studies: Califf

FDA commissioner Robert Califf calls on health insurers to play a role in seeing that confirmatory trials are completed for drugs approved through the...

Clinical Investigation Electronic Systems Guidance

FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.