On May 25, 2022, the U.S. Food and Drug Administration (FDA) issued a guidance document intended to help pharmacists and wholesale drug distributors understand and comply with its final rule regarding the import of certain...more
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
The latest issue of The Life Sciences Report features an interview with Matthew J. Meyer, the firm's chief client corporate development officer, who has broad management experience in the life sciences sector; a piece...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
U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more
3/9/2020
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
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
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products -
The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
6/24/2019
/ Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
HIPAA Privacy Rule ,
Life Sciences ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Popular ,
Pre-Market Notification ,
Regulatory Oversight ,
Regulatory Standards
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
Machine Learning and Digital Health Applications -
The use of artificial intelligence (AI) algorithms to solve complex problems has risen dramatically in the last several years. In 2017, Gartner identified more than 1,000...more
3/9/2018
/ Digital Health ,
Health Care Providers ,
Innovative Technology ,
Life Sciences ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Data ,
PHI ,
Section 101
Life Beyond FDA Clearance or Approval: The Reimbursement Challenge -
To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more
1/11/2018
/ Corporate Financing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Initial Public Offering (IPO) ,
Life Sciences ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Reimbursements ,
Venture Capital
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
Consumer Digital Health: Market Shift Is Leading to New Opportunities -
The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more
The Future of Innovation in Medtech: An Industry in Search of Growth While Facing Pressures to Consolidate in a Post-ACA World -
In the Affordable Care Act (ACA) era, the healthcare industry has witnessed significant...more
Ten Considerations for Companies Evaluating a Pre-Negotiated Acquisition -
In recent years, there has been a shift in the research and development strategy of large pharmaceutical and medical device companies from...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:
- How to Expedite Examination of a Patent Application
- The FDA Releases Final Guidance for Mobile Medical Applications
- Creating Value in the Medtech Industry Using a Gender Lens
-...more
10/4/2013
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Mobile Apps ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Telemedicine ,
USPTO ,
Venture Capital