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Medmarc Blog (blog.medmarc.com)

FDA Seeks Feedback on AI in Drug Development, Manufacturing

May 23, 2023

The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...

FTC Proposes to Prohibit Non-compete Clauses in Employment Contracts

May 15, 2023

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

April 12, 2023

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...

The Modernization of Cosmetics Regulation Act of 2022

March 28, 2023

Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization...

AdvaMed’s Innovation Agenda Highlights Patient Access, FDA Regulation

March 23, 2023

The Advanced Medical Technology Association (AdvaMed) has developed an innovation agenda for the 118th Congress, which emphasizes nine top priorities, such as the reinstatement of expensing for...

FTC Broadens Reach of Health Products Compliance Guidance

March 06, 2023

In December 2022, the Federal Trade Commission released an update to a 1998 set of guidelines for advertising and promotion of health products, but while the 1998 guidance was understood to...

New Extension Proposed for European Union’s Medical Device Regulation

January 24, 2023

Timelines for compliance with the European Union’s Medical Device Regulation (MDR) may be extended again via a legislative proposal recently released by the European Commission (EC), which would...

FDA Reissues CRL Guidance for Generic Drugs After Five Months

January 20, 2023

The FDA has reissued a July 2022 guidance for complete response letters (CRLs) for generic drug applications after only five months, although the December 2022 version was made necessary by the...

Congress Passes Budget Omnibus without VALID Act

December 28, 2022

The U.S. Senate and House of Representatives have concluded their work on the budget for fiscal year 2023, sending the Consolidated Appropriations Act (CAA) to the White House for President...