FDA has, once again, reminded sponsors that ClinicalTrials.gov results reporting is not optional. In a March 30, 2026 outreach, the Agency contacted more than 2,200 sponsors and investigators associated with over 3,000 clinical trials that appear to be missing required results submissions to ClinicalTrials.gov or have …
Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had …
On January 21, 2025, the Trump administration withdrew FDA’s proposed ban on menthol cigarettes, which the Biden administration initially introduced in 2022. This move is the latest step in FDA’s long, uncertain, and controversial journey to ban menthol cigarettes. For some background (which is covered in …
During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of …
The trio of CDER, CBER, and CDRH released a new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance. The new …
You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. To quote the Fifth Circuit: “It was the regulatory equivalent of Romeo sending Mercutio on a wild goose chase—and then …
In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”). This Draft Guidance, in …
The Draft Guidance In February 2023, CDER, CBER, and the Oncology Center of Excellence published a draft guidance titled “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products” (the “Draft Guidance”) to provide recommendations to those considering the use of …
On October 12, 2021, FDA authorized the marketing of R.J. Reynolds (RJR) Vapor Company’s Vuse Solo electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. …
It seems that although FDA giveth, the ITC taketh away. IQOS is a tobacco heating system in which “heatsticks” (reconstituted tobacco blended with glycerin) are electrically heated to release nicotine-containing aerosol, but the tobacco is not combusted. Because IQOS was classified as a cigarette by FDA, …
NDA approval – that pinnacle of drug development – marks a moment of success for both FDA and the drug applicant. The regulated and the regulator, having worked together for years, place a novel or improved therapy, with adequate directions for its use, in the …
The Food & Drug Administration (FDA) announced on April 29, 2021 that it is working towards banning menthol flavored cigarettes, committing itself to issuing a proposed product standard to prohibit menthol as a characterizing flavor in cigarettes “within the next year.” In the same announcement, …
The Priority Review Voucher (“PRV”) program is a powerful incentive to encourage sponsors to develop treatments for conditions that are not ordinarily priorities for industry, such as infectious diseases for which there is no significant market in developed nations (tropical disease) or rare pediatric diseases. …
In the White House coronavirus updates, President Trump has commended FDA for working “around the clock” to expedite the review of new medical products to help with the testing and treatment of COVID-19. This is not puffery, as we at HP&M have experienced lightning fast …
The COVID-19 pandemic has had a significant impact on day-to-day life for all of us in an attempt to “flatten the curve” to slow transmission of the coronavirus (SARS-CoV-2). However, for those of us involved in the development of medical products, quarantines, site closures, travel …
