News & Analysis as of

Controlled Substances FDA Approval

Womble Bond Dickinson

Unlocking the Secrets of the Endocannabinoid System: A New Frontier in Therapeutic Cannabis Research for Adolescents

Womble Bond Dickinson on

Humans possess several well-established bodily systems, including the sympathetic nervous system, the central nervous system, and the endocrine system. A relatively recent discovery is the endocannabinoid system (ECS)....more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

Quarles & Brady LLP on

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products

The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022, which provides that the agency plans to issue 18 guidance documents in 2022,...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Womble Bond Dickinson

Oral Film Medication Delivery of Psychedelics: A Game Changer to Treat Depression?

Womble Bond Dickinson on

Over 300 million people live with depression worldwide. WHO estimates that almost 800,000 people die annually from suicide. Although antidepressants and counseling can be effective treatments for many individuals, there is...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Update on Florida’s Canadian Prescription Drug Importation Program

This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more

Knobbe Martens

First CBD Drug Receives FDA Approval

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The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United States. The announcement notes that Epidiolex contains a highly...more

Knobbe Martens

The FDA Approves Active Ingredient Derived from Marijuana to Treat Epilepsy

Knobbe Martens on

On June 25th, 2018, the U.S. Food and Drug Administration (FDA) approved the drug, Epidiolex, for the treatment of seizures associated with two rare forms of epilepsy, Dravet syndrome, and Lennox-Gastaut syndrome. The active...more

Knobbe Martens

FDA Approves Final Label for Syndros™

Knobbe Martens on

On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™ (dronabinol) oral solution, a Schedule II (CII) controlled substance. Syndros™ was initially approved by the FDA on July 5, 2016...more

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