On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its regulatory expectations for...more
On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
6/7/2019
/ Biologics ,
Food and Drug Administration (FDA) ,
Fraudulent Marketing ,
Health Care Providers ,
Health Clinics ,
Life Sciences ,
Pharmaceutical Industry ,
PHSA ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more
5/14/2018
/ Commercial Marketing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Patient Safety ,
Pharmaceutical Industry ,
Regenerative Medicine ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more
6/14/2017
/ Abbreviated New Drug Application (ANDA) ,
Certification Requirements ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Guidance Update ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Standards