In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/13/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old...more
8/27/2020
/ CLIA ,
Consent Agreements ,
Contact Tracing ,
Educational Institutions ,
Emergency Use Authorization (EUA) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Mobile Apps ,
Quarantine ,
Re-Opening Guidelines ,
Remote Learning ,
Research and Development ,
Sanctions ,
Screening Procedures ,
Universities ,
Virus Testing ,
Waivers
The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more
Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more
5/5/2020
/ Acquisitions ,
Contact Tracing ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Divestiture ,
Due Diligence ,
Foreign Investment ,
Health Care Providers ,
Intellectual Property Protection ,
Joint Venture ,
Life Sciences ,
Medical Testing ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Vaccinations ,
Virus Testing ,
Webinars
The Food and Drug Administration issued an enforcement policy on the use of digital health devices that are considered therapeutic for psychiatric disorders during the Coronavirus (COVID-19) public health emergency. The...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more
4/10/2020
/ Best Practices ,
Biologics ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Face-Filtering ,
Health and Safety ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Medical Devices ,
OSHA ,
Personal Protective Equipment ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more
As part of its initiatives to expedite access to investigational drugs or biologics for the treatment of Coronavirus (COVID-19), on March 24, 2020, the US Food and Drug Administration announced that healthcare providers may...more
The Centers for Medicare and Medicaid Services has temporarily modified certain operational and regulatory requirements that may help Clinical Laboratory Improvement Amendments (CLIA) certified laboratories adapt their...more
In a series of notices and enforcement-policy statements, the FDA has announced additional efforts to address the critical shortage of face masks, filtering facepiece respirators (FFRs) and ventilators in response to the...more
The US Food and Drug Administration (FDA) announced several initiatives to increase access to ventilators and other respiratory devices during the Coronavirus (COVID-19) pandemic, as well as relaxed enforcement of certain...more
The Coronavirus (COVID-19) pandemic presents significant challenges for clinical trial sponsors. The US Food and Drug Administration issued guidance on March 19, 2020, that provides greater flexibility to adjust clinical...more
On March 20, 2020, the US Food and Drug Administration announced updates to its enforcement policy on the use of non-invasive remote monitoring devices, specifically for uses designed to support patient monitoring during the...more
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
3/13/2020
/ Appropriations Bill ,
Biologics ,
China ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Response ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
Medical Devices ,
National Institute of Allergy and Infectious Diseases (NIAID) ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Risk Management ,
Risk Mitigation ,
Supply Chain ,
Vaccinations
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
1/14/2020
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight
Digital health and other life sciences/tech developers, particularly those producing innovative new solutions, offer dynamic opportunities for investors, in part due to the continued evolution of the US Food and Drug...more
12/2/2019
/ Biologics ,
Collaboration ,
Digital Health ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hospitals ,
Innovation ,
Investment Management ,
Investors ,
Life Sciences ,
Medical Devices ,
Risk Management ,
Startups
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
10/17/2019
/ 21st Century Cures Act ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software
McDermott’s cross-functional team of life sciences professionals present the second annual Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
3/13/2019
/ Collaboration ,
Continuing Legal Education ,
Corporate Counsel ,
Events ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Patent Portfolios ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Strategic Partnerships
INTRODUCTION -
The US Food and Drug Administration’s (FDA’s) 2018 regulatory agenda spurred significant activity throughout the year, including implementation of several initiatives and mandates required by the 21st...more
Where Things Stood -
Understanding the impact of what we have seen so far this year first requires an understanding of where we were at the end of 2017, with respect to both Medicare reimbursement and provider adoption of...more