Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

Clinical Research 98

Clinical Research Research Clinical Trials Compliance 98

The Pharma Data

NOVEMBER 11, 2020

and EU5 by 2026. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada.

Therapies 40

Therapies Disease Marketing Clinical Research 40

The Pharma Data

DECEMBER 16, 2020

and EU5 by 2026. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada.

Therapies 40

Therapies Disease Marketing Clinical Research 40

The Pharma Data

OCTOBER 14, 2020

He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. and EU5 by 2026. The DSR therapy is not currently approved for clinical research in the United States or Canada. Source link.

Clinical Trials 40

Clinical Trials Therapies Clinical Research Trials 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40