Newsletters

12.13.23

FDA Receives Application for Approval of MDMA-Assisted Therapy

On December 12, 2023, the MAPS Public Benefit Corporation (MAPS PBC) announced the submission of a marketing application to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine capsules) in combination with psychological intervention by a qualified health care provider (including ...


10.30.23

Achieving Clinical Trial Diversity: Expanding Hospital Capacity to Offer Trials in the Community

The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited.


08.21.23

5th Circuit Rejects FDA Actions Expanding Access to Medication Abortion; Supreme Court Review Likely

On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills taken in a medication abortion.


06.28.23

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up.


04.14.23

Federal Courts Divided: Medication Abortion and the Uncertain Future of FDA’s Drug Oversight

Less than one year after the Supreme Court overturned the federal constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization and “returned [the issue of abortion back] to the people and their elected representatives,” access to safe and legal abortion ...


03.23.23

FDA Announces the Discontinuation of Certain COVID-19-Related Guidance Documents

The United States Food and Drug Administration published a notice in the Federal Register on March 13, 2023, addressing the agency’s various COVID-19-related guidance documents issued by all of the medical product centers.


01.30.23

FDA Stands By Long-standing Interpretation of the Orphan Drug Act…For Now

On January 24, the Food and Drug Administration made a long-awaited announcement with major implications for how the agency awards exclusivity for rare disease drugs under the Orphan Drug Act.


01.23.23

ICYMI: A New Year and New Guidance From FTC on ‘Health Products’ Advertising

On December 20, 2022, amidst a flurry of end-of-year activity on Capitol Hill, the Federal Trade Commission’s (FTC) Bureau of Consumer Protection issued a major update of its over two-decades-old guidance titled “Dietary Supplements: An Advertising Guide for Industry” (1998 ...


01.17.23

FDA and DOJ Take Significant Steps Designed to Expand Access to Medication Abortion

On January 3, the Biden Administration took additional steps to ease access to FDA-approved abortion medication in the United States, further wading into the legal and political chaos that has sprung up in the wake of the decision by the Supreme Court in the case of Dobbs v. Jackson Women’s ...


12.13.22

Abortion Pill Opponents Challenge FDA’s Approval of Mifepristone

Since the Supreme Court overturned the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization earlier this year, demand for medication abortion through the Food and Drug Administration approved drug mifepristone has exponentially increased.