article thumbnail

The FDA Backdoor to MDMA Rescheduling

Bill of Health

Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. However, in 2016, DEA added some clarity to the “accepted medical use” qualification, saying that FDA approval was one way to achieve this threshold.

FDA 202
article thumbnail

Pig Hearts for Humans and the FDA

Bill of Health

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use” ). Categorization.

FDA 325
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Understanding the FDA Debarment List

Compliancy Group

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

FDA 52
article thumbnail

FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

Bill of Health

Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. By Matthew Chun The U.S. manufacturing process design), implement advanced process controls (e.g.,

FDA 264
article thumbnail

Federal judge invalidates FDA approval of abortion pill

Healthcare Dive

approval, and could carry consequences for the FDA’s authority over prescription medicines. The decision imperils access to the drug more than two decades after its U.S.

FDA 264
article thumbnail

FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show

Healthcare Dive

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

FDA 264
article thumbnail

Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

Bill of Health

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. By Matthew Chun.

FDA 264