FDA recently released a draft guidance, titled “Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products,” that provides valuable direction and insight into how sponsors can (and should) approach long-term data collection once a cell and gene therapy (CGT) product …
On September 11, 2025, Reps. Diana Harshbarger (R-TN) and Buddy Carter (R-GA)—the only two pharmacists in the U.S. House of Representatives—introduced a new bill, titled “Drug Shortage Compounding Patient Access Act” (H.R. 5316), that would expand the ability of compounding pharmacies and outsourcing facilities to …
There are officially signs of life for FDA’s rare pediatric disease priority review voucher (RPD PRV) program! On September 17, the House Committee on Energy and Commerce marked up the Give Kids a Chance Act of 2025 (H.R. 1262), legislation that would reauthorize FDA’s RPD …
Since 2009, the term ultra-processed food (“UPF”) has gained recognition as there have been studies that suggest a relationship between consumption of UPFs and chronic diseases. The term frequently focuses on processing and composition without consideration of food groups and nutritional composition. At this time, …
On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. …
A recent appellate court decision vacating a Federal Trade Commission (“FTC”) rule on procedural grounds may spell the end of the effort to implement the “Negative Option Rule.” For any blog reader who has ever missed that cancellation deadline and found themselves saddled with another month …
On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025. Under the titular theme “Ensuring Accountability and Prioritizing Public …
Two southern states are taking bold steps to change the way they approach food labeling—and they’re not mincing words. In a growing movement aligned with the “Make America Healthy Again” (MAHA) agenda, Texas and Louisiana have each passed sweeping new laws requiring clearer warnings and …
Recently, FDA announced a deadline shift, although the Agency did so quietly. On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently …
Since the U.S. Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its regulatory oversight for over-the-counter (OTC) products. But five years in, the Agency’s OMUFA Facility Arrears List …
In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Senator Dick Durbin (D-IL) expressed concerns over the agency’s ability to regulate direct-to-consumer (“DTC”) prescription drug advertisements following recent workforce reductions. In his letter, Senator Durbin highlighted FDA’s critical role in ensuring that pharmaceutical …
Operation Stork Speed is a go! On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United …
On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States (link, link). This initiative …
On January 7, 2025, FDA announced that back on November 12, 2024, the Center for Veterinary Medicine (“CVM”) issued Warning Letters to six online retailers marketing unapproved new animal drug products that purported to treat and control seizures and epilepsy in dogs and cats. At …
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 …
