Andrea Chamblee

Wilson Sonsini Goodrich & Rosati

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FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products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

8/15/2022 / Center for Biologics Evaluation and Research (CBER) , Clinical Trials , Controlled Substances , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

FDA Warns Companies Illegally Selling CBD and Delta-8 THC Products

On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more

5/13/2022 / Cannabidiol (CBD) oil , Cannabis-Related Businesses (CRBs) , Decriminalization of Marijuana , Food and Drug Administration (FDA) , Life Sciences , Marijuana-Infused Edibles , Medical Marijuana , Pharmaceutical Industry , Prescription Drugs , THC

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

4/26/2022 / Consumer Product Safety Commission (CPSC) , Coronavirus/COVID-19 , Corporate Counsel , Department of Justice (DOJ) , Food and Drug Administration (FDA) , Healthcare , Healthcare Fraud , Opioid , Pfizer , Pharmaceutical Industry , Popular , Purdue Pharma , Vaccinations

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