On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more
Investments in new (“greenfield”) or expanded (“brownfield,” “retrofit”) domestic manufacturing capabilities require years of strategic planning and capital expenditure. Even with the announcement of near-term incentives and...more
The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more
On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development and assessment of applications for...more
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,” which offers...more
The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or biological product, including Accelerated Approval, which allows for approval of...more
In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of...more
On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more
Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly...more
A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more
This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for drug development programs. The draft...more
Last week, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled Substances Act. ...more