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Prescription Drugs › Trump Administration › FDA Approval

Pullman & Comley - Connecticut Health Law

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

Pullman & Comley - Connecticut Health Law on

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

Hogan Lovells

HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval

Hogan Lovells on

On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI)....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 15

Hogan Lovells on

In Washington: After several consecutive days of talks between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin it appears increasingly likely that Congress will have to wait to consider any COVID-19...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma under fire over quality, safety, and patents on costly brand drugs

Patrick Malone & Associates P.C. | DC Injury... on

When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Wilson Sonsini Goodrich & Rosati

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

Wilson Sonsini Goodrich & Rosati on

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

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

Hogan Lovells

New Legislation Increases Access to Medical Products for Military Applications

Hogan Lovells on

Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more

Searcy Denney Scarola Barnhart & Shipley

What Does the Cures Act Really Mean for Patients?

Searcy Denney Scarola Barnhart & Shipley on

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

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