On Monday, Feb. 23, the Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic...more
The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device products, especially...more
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
This week, the government shutdown entered its fifth week and, on Nov. 4, 2025, became the longest in history, beating a 34-day-plus record set during President Donald Trump's first term. Meanwhile, the Open Enrollment Period...more
As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently gathered in Boston to discuss shifting regulatory paradigms under the Trump administration's Food and Drug Administration...more
On September 3, 2025, the FDA announced the RDEP, a new framework intended to accelerate the approval of treatments for ultra-rare genetic diseases.1 The RDEP was jointly developed by the Center for Drug Evaluation and...more
On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence.”...more
On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more
The life sciences industry is well positioned for growth in 2025, fueled by strong investor interest and technological advancements, especially in AI. Life sciences venture capital (VC) funding and IPOs have picked up in...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance...more
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more
Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....more
On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics Evaluation and Research (“CBER”)...more
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s performance in moving...more