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 199
article thumbnail

Anti-Abortion Advocacy Groups’ Challenge to FDA-Approved Abortion Pill May Have Far-Reaching Consequences

Health Law Advisor

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

FDA 59
Insiders

Sign Up for our Newsletter

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

article thumbnail

Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

Healthcare Law Blog

FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Judge James Ho wrote separately, agreeing with the majority to set aside the 2016 and 2021 REMS modifications.

FDA 52
article thumbnail

Gender-Affirming Care, Abortion, and the Politics of Science: A Response to Wuest’s ‘Born this Way’

Bill of Health

Most recently, in the context of medical abortion, conservatives have tried to undermine and roll back FDA approval of mifepristone by raising concerns about whether the approval of the drug itself was based on adequate evidence. A simultaneous shift in approved gestation period and dosage for mifepristone use.)

FDA 209
article thumbnail

Cerner CEO pledges to zero-out 'noise' from EHRs, population health and revenue cycle

Healthcare It News

Five years ago, in his then-capacity as president and chief executive officer of Geisinger , Dr. David Feinberg keynoted Day 4 of the 2016 annual Cerner Health Conference. "That same year, FDA approved smart pills. Records should help nurses and doctors avoid errors and suggest what treatments might be best.

article thumbnail

New CDC Opioid Guidelines: Too Little, Too Late for Chronic Pain Patients?

Kaiser Health News

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain. The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same.

Doctors 88
article thumbnail

The Heart of Health at CES 2020 – Evidence & Innovation Bridge Consumers and Doctors

Health Populi

In Valencell’s recent survey of consumer wearable preferences , 55% of people said they’d like to monitor blood pressure, up from 46% in 2016 as shown in this bar chart from the study. The post The Heart of Health at CES 2020 – Evidence & Innovation Bridge Consumers and Doctors appeared first on HealthPopuli.com.

Doctors 88