The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
12/20/2019
/ 510(k) RTA ,
FDA Approval ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pre-Market Notification ,
Premarket Approval Applications ,
Prescription Drugs ,
Regulatory Burden ,
Statutory Interpretation ,
Venture Capital
Recently, Stat+ reported that a group of prominent venture capitalists (VCs) issued a strong warning to Congress. The warning: H.R. 3, the newly introduced Lower Drug Costs Now Act, if enacted, will "severely constrain" the...more
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
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:
- Best Patent Practices Under the America Invents Act
- CMS Issues Final Rule for Implementing Sunshine Act
- New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more