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Federal Register notice: FDA posts a draft guidance with information for sponsors who are developing certain local anesthetic drug...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

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

Senate Appropriators Announce 4/19 FDA Budget Hearing

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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

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

Community Should Push AA Drug Studies: Califf

[ Price : $8.95]

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

Clinical Investigation Electronic Systems Guidance

[ Price : $8.95]

FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated p...