April 15, 2024
(Reuters) – U.S. employers’ obligation to accommodate workers’ pregnancies also extends to abortions and the use of contraception, the U.S. agency that enforces workplace discrimination laws […]
April 15, 2024
Hand Sanitizer NA LIQUID Cardinal Spirits Hand Sanitizer sampling and testing Assay, Impurities Passed Assay; Failed Impurities Hand Sanitizer Seatex Hand Sanitizer Alcohol Antisepetic 80% Topical […]
April 15, 2024
Seizure burden, defined by an artificial intelligence (AI) algorithm applied to point-of-care electroencephalography (POC EEG) recordings, can help predict functional outcomes. After relevant cofactors were controlled […]
April 15, 2024
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process […]
April 15, 2024
Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Recently I had the privilege of official travel to the U.K. and European Union (EU) […]
April 15, 2024
Docket Number: FDA-2019-D-3132 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of investigational new drug applications […]
April 15, 2024
4/15/2024 FDA establishes CDER Center for Clinical Trial Innovation (C3TI) 3/25/2024 CDER Establishes New Quantitative Medicine Center of Excellence 3/15/2024 FDA Announces New Quality Oversight Webpage […]
April 15, 2024
[4/15/2024] Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to […]
April 15, 2024
Content and Format of the C3TI Demonstration Program Proposal The C3TI Demonstration Program proposal should include the information below and not exceed 10 pages. The sponsor […]
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