As the summer of 2025 comes to a close and we begin to look toward to the 2026 Fiscal Year, FDA is completing its reporting on 2024. The FDA’s fiscal year 2024 Report on the State of Pharmaceutical Quality from CDER’s Office of Pharmaceutical Quality …
CDER’s Office of Pharmaceutical Quality (OPQ) recently published a white paper called Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective. Not entirely a financial analysis, OPQ is making what amounts to a two-part sales pitch to pharma execs that investment in manufacturing quality …
One familiar with homeopathy might reasonably think that the practice would have a place in the Make America Healthy Again movement as an alternative to conventional pharmaceutical treatment. But after a recent court decision issued on July 15, 2025, the regulatory path for homeopathic medicine …
Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institute’s Annual Conference, continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Now firmly in the chair after the agency’s controversial RIFs—which he …
On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. consumers. The stated goals are to ensure that “foreign companies will receive the same level …
Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functions—and as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As …
Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. to 1:30 p.m. (ET) (register here). Join us as HPM’s Anne Walsh moderates a panel …
Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless of your position on the correctness of the holdings or the reasoning behind …
The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the cuts at FDA impact inspections and enforcement? Will there be a heightened appetite for mergers and …
During the Regulatory Freeze Pending Review and the HHS Immediate Pause on Issuing Documents and Public Communications, our thoughts turned to the principles underlying the Freedom of Information Act (FOIA). As the DOJ FOIA Guide explains in its introduction: The United States Supreme Court has explained …
The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services kick off at 10 am on January 29 and promise to have a packed agenda. With oversight over FDA, the Centers for Medicare & Medicaid Services, the National …
Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and …
As we reported back in January, Phibro Animal Health Corporation challenged FDA’s decision to remove a drug called carbadox—used as an antimicrobial drug to treat gastrointestinal disease in food-producing pigs—from the market. More specifically, FDA rescinded approval of a “regulatory method” that Phibro used to …
Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. …
On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting …
