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Prescription Drugs › Breakthrough Therapy Designation

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Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission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Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more

Robinson+Cole Health Law Diagnosis

Connecticut Makes Significant Changes to its Collaborative Drug Therapy Laws

Robinson+Cole Health Law Diagnosis on

As part of Connecticut’s budget implementer bill (Act) signed into law earlier this month, the state made significant revisions to its laws concerning collaborative drug therapy management agreements between pharmacists and...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

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