Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more
The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more
7/21/2020
/ Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Coronavirus/COVID-19 ,
Enforcement Authority ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Regulatory Requirements ,
Relief Measures
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
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
12/13/2017
/ Department of Defense (DOD) ,
Expedited FDA Approval ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Military Service Members ,
NDAA ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Trump Administration