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May 11, 2023

Speech by Robert M. Califf, M.D. to the National Health Council’s 2023 Science for Patient Engagement Symposium — Patient Empowerment in the Digital Health Era – 05/08/2023

Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) I’m delighted to be with you as part of this important meeting to discuss […]
May 11, 2023

Qué preguntar a su médico antes de tomar opiáceos

Image English Cada paciente debe hacer preguntas al obtener una nueva receta médica. Esto es especialmente importante cuando su médico, dentista u otro profesional de atención […]
May 11, 2023

Decentralized Clinical Trials (DCT) Draft Guidance – 06/20/2023

On This Page Date: June 20, 2023 Time: 3:00 PM – 4:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR The […]
May 11, 2023

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

For Immediate Release: May 11, 2023 Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment […]
May 11, 2023

Overview: Clinical Pharmacology Considerations for Food Effect Studies – 06/15/2023

On This Page Date: June 15, 2023 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR In […]
May 10, 2023

The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions

FDA has the authority under section 582(a)(3) of the Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), […]
May 10, 2023

Artificial Intelligence and Machine Learning (AI/ML) for Drug Development

What is Artificial Intelligence and Machine Learning? Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering […]
May 10, 2023

What to Ask Your Doctor Before Taking Opioids

Image Español Every patient should ask questions when getting a new prescription. This is especially important when your doctor, dentist or other health care professional prescribes […]
May 10, 2023

FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

Image By: Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research Artificial intelligence (AI) and machine learning (ML) are no longer futuristic concepts; […]
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