President Joe Biden was sworn into office on January 20, 2021. As with any incoming administration, new policies will be pursued while those of the previous administration are furthered, abandoned, or undone. The federal...more
3/1/2021
/ Biden Administration ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Physicians ,
Popular
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more
On November 17, 2020, nine months after the start of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Lucira Health for the first COVID-19 diagnostic test for...more
Last week, the U.S. Food and Drug Administration (FDA) took a significant step towards increased regulation of 503A human drug compounding pharmacies, which may cascade into additional state regulation. 503A compounding...more
With the 2020 Presidential election upon us, many members of the cannabidiol (CBD) and cannabis (marijuana) product industries, as well as consumers alike, are wondering if the election will result in policy changes that...more
11/3/2020
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
General Elections ,
Hemp Cultivation ,
Hemp Related Businesses ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Popular
The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more
The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more
The U.S. Food and Drug Administration (FDA) recently issued draft guidance to further the development of drugs that contain cannabis and compounds found in cannabis, acknowledging the growing interest in this area. The...more
In a move welcomed by industry, the Food and Drug Administration (FDA) has granted six additional months of enforcement discretion to manufacturers of certain human cell, tissue, or cellular or tissue-based products (HCT/Ps)....more
When the COVID-19 pandemic struck the U.S., manufacturers regulated by the Food and Drug Administration (FDA) were afforded some relief from agency inspections, allowing time to focus on adapting to a new norm. Roughly four...more
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents outlining the agency's expectations for COVID-19 drug development. The first guidance, "COVID-19 Public Health Emergency: General...more
The U.S. Food and Drug Administration (FDA) recently eased a significant regulatory barrier to at-home COVID-19 testing. On May 6, 2020, the FDA issued a policy facilitating patient access to sample collection kits in a step...more
During this unprecedented time, digital health is disrupting our healthcare delivery system for the better. Digital health companies are working hard to provide innovative telehealth, digital screening, and testing services....more
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), a $2 trillion stimulus package thought to be the largest in U.S. history. This is the third stimulus package adopted...more
Many global markets have been impacted by COVID-19, including the medical product and food industries. Both sectors are particularly critical as medical products are relied upon to help abate the disease and as communities...more
The U.S. Food and Drug Administration (FDA) re-opened a docket this week seeking scientific data and information about products containing cannabis or cannabis-derived compounds such as cannabidiol (CBD). This move is...more
The U.S. Food and Drug Administration (FDA) released a statement last week describing recent efforts in the agency's evaluation of cannabidiol (CBD). The statement is of particular interest to stakeholders in the cannabis...more
The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more
2/3/2020
/ 510(k) RTA ,
Artificial Intelligence ,
Deregulation ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Medical Devices ,
Premarket Approval Applications ,
Public Workshops ,
Regulatory Burden ,
Regulatory Reform ,
Software
USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies -
On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more
1/7/2020
/ Biologics ,
Collaboration ,
Digital Health ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovation ,
Investors ,
Japan ,
Life Sciences ,
Medical Devices ,
Startups ,
Venture Capital
Beware of “Most Favored Nations” Clauses in Commercial Contracts -
Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more
11/20/2019
/ Antitrust Violations ,
Competition ,
Contract Negotiations ,
Cybersecurity ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medical Devices ,
Most-Favored Nations ,
Patient Privacy Rights ,
PHI ,
Preferred Hospital Networks Arrangement
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
/ Biotechnology ,
California Consumer Privacy Act (CCPA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Consumer Product Safety Commission (CPSC) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Technology-Assisted Review ,
Telemedicine ,
Value-Added Services