Medmarc Blog (blog.medmarc.com)
Life Sciences Industry (7)
FDA Releases New Draft Guidance for Unapproved Uses
The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available. This is a reissue of a...
A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability
The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...
FDA Proposes End to Enforcement Discretion for Lab-Developed Tests
The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The...
New FDA Draft Guidance Offers Clarity for 510(k) Requirements
The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program. When...
AdvaMed and CapView Propose Plan for Medicare Coverage of AI
The Advanced Medical Technology Association (AdvaMed) and CapView Strategies have collaborated to produce a series of recommendations for improving Medicare coverage of artificial intelligence (AI),...
Medicare Rule for Breakthrough Devices Returns
The Centers for Medicare and Medicaid Services has resubmitted the rule for Medicare coverage of FDA breakthrough devices with a modified plan for the application and for the process of...
FTC Seeks to Expand Scope of Breach Notification Rule
The Federal Trade Commission has issued a proposal to update the Health Breach Notification Rule (HBNR) that expands the sweep of the rule to functions and products not previously within the...
WHO Urges Nations to Adopt National Strategies for Diagnostics
In the wake of the COVID-19 pandemic, the World Health Organization has adopted a resolution that has received the backing of MedTech Europe and the Advanced Medical Technology Association...
FTC Proposes to Prohibit Non-compete Clauses in Employment Contracts
The Federal Trade Commission has proposed to ban the practice of adding non-compete clauses to employment contracts, which the FTC states are an impediment to competition. In comments on the...
FDA Seeks Budget Authority Increase of 10% in Fiscal Year 2024
The Office of Management and Budget has released a budget request for fiscal year 2024 for all departments of the federal government, including a proposed budget for the FDA. This includes an...