News & Analysis as of

Clinical Trials Prescription Drugs Trump Administration

Pullman & Comley - Connecticut Health Law

A Progress Report on Psychedelic Drug Legislation in Connecticut and Nearby States

The burgeoning field of psychedelic medicine, which suffered a major setback last year when the Food and Drug Administration (FDA) rejected an application to approve the use of midomafetamine (MDMA) to treat post-traumatic...more

Bradley Arant Boult Cummings LLP

Makary Says Psychedelics Are Maybe Okay, M’Kay?

Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last...more

Holland & Knight LLP

Food and Chemical Regulatory Update: The Make Our Children Healthy Again Assessment

Holland & Knight LLP on

The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 3

Hogan Lovells on

In Washington - Senate Majority Leader Mitch McConnell (R-KY) and Republicans released the text of their “skinny” or “targeted” coronavirus relief bill. McConnell said a vote to proceed to the bill is expected Thursday....more

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more

Sunstein LLP

July 2018 IP Update: The Right to Try Act: A New Avenue for Use of Experimental Drugs

Sunstein LLP on

On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more

Holland & Knight LLP

Right to Try Law Enacted by Congress: Implementation Unclear

Holland & Knight LLP on

On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

Holland & Knight LLP on

On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

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