Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
4/26/2022
/ Consumer Product Safety Commission (CPSC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Opioid ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Purdue Pharma ,
Vaccinations
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more
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 March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs
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
Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more
Factoring in Human Factors -
According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more
In This Issue:
- The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities
- Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers
- Life...more
6/24/2015
/ Department of Justice (DOJ) ,
Diagnostic Tests ,
Emerging Growth Companies ,
Enforcement Actions ,
Equity Financing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Human Genome Project ,
Initial Public Offering (IPO) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Myriad ,
Patent Infringement ,
Patents ,
Personalized Medicine ,
Venture Capital
In this issue:
- A New Accelerator Takes Digital Health Start-Ups to the Next Level
- The Return of the MedTech IPO Market
- Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters
-...more