Earlier this week, efforts to reduce U.S. reliance on biotechnology companies in China stalled when the BIOSECURE Act (“BIOSECURE” or the “Act”) was left out of this week’s continuing resolution (CR). As a result, BIOSECURE...more
Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more
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
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 July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...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
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
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
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more
11/8/2018
/ Biotechnology ,
Department of Defense (DOD) ,
Expedited FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Memorandum of Understanding ,
Military Service Members ,
Pharmaceutical Industry ,
Prescription Drugs ,
Priority Rules ,
Regulatory Requirements
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
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
Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
8/22/2017
/ Abbreviated New Drug Application (ANDA) ,
Biotechnology ,
Drug Design ,
Drug Pricing ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Innovation ,
Medical Devices ,
New Legislation ,
Orphan Drugs ,
PDUFA ,
Pediatrics ,
Prescription Drugs ,
Product Labels ,
Regulatory Oversight ,
Trump Administration ,
User Fees