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Food and Drug Administration (FDA) › Breakthrough Therapy Designation

Foley & Lardner LLP

Psychedelic Drugs – Easing the Regulatory Hurdles for Development

Foley & Lardner LLP on

Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more

Arnall Golden Gregory LLP

Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission

Arnall Golden Gregory LLP on

In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft...more

Hogan Lovells

FDA outlines rescission of Breakthrough Therapy Designation - Guidance potentially signals closer agency scrutiny of designations...

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more

Knobbe Martens

Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM

Knobbe Martens on

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...more

Womble Bond Dickinson

Psilocybin May Brighten the Future for Depression Patients

Womble Bond Dickinson on

The Struggle is Real - Over 17 million people in the United States are diagnosed with major depressive disorder (MDD). Antidepressants and psychotherapy are the leading forms of treatment; however, antidepressants are not...more

Seyfarth Shaw LLP

FDA Announces the Creation of CTAP—Coronavirus Treatment Acceleration Program—to Assist Drug Developers and Evaluators

Seyfarth Shaw LLP on

The US Food and Drug Administration (FDA) is prioritizing the development and review of new therapies to treat COVID-19 through a recently created special emergency program titled Coronavirus Treatment Acceleration Program...more

Hogan Lovells

FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

Hogan Lovells on

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that...more

McDermott Will & Emery

FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

McDermott Will & Emery on

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of...more

Knobbe Martens

FDA Grants Breakthrough Status to Dthera Sciences' Alzheimer's Therapeutic

Knobbe Martens on

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance on Breakthrough Devices Program

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

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