FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections. FDA has initiated a public consultation period, seeking feedback on the guidance and how its recommendations should be applied to increasingly diverse trial types and data sources.
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Reassessing Drug Inspection Targets: FDA Updates Internal Policy for Risk-Based Site Selection Model
In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy).
As drug shortages are once again front-page crises news, demanding drastic action by FDA—currently with a particular focus on sterile, injectable platinum-based chemotherapy drugs—a refresher on the scope of FDA’s tools to address a drug shortage is useful.
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.
The Boston Bar Association held its annual White Collar Crime Conference on May 4, 2023, featuring lawyers from the defense and plaintiffs’ bar and current and former prosecutors from the US Attorney’s Office for the District of Massachusetts (Office) and the Office of the Massachusetts Attorney General.
The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. The final guidance follows the passage of the Medical Marijuana and Cannabidiol Research Expansion Act and provides key clarifications on quality requirements for cannabis and cannabis-derived compounds used in clinical research.
While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is keeping an eye on how FDA approves orphan drug products.
The Civil Division of the US Department of Justice (DOJ) released its annual fraud statistics for fiscal year 2022 on February 7. Of the $2.2 billion recovered under False Claims Act (FCA) settlements and judgments, more than $1.7 billion related to matters that involved the healthcare industry, including medical device and pharmaceutical manufacturers.
The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway before a clinical benefit has been confirmed by the required confirmatory studies.
The US Food and Drug Administration (FDA) recently issued a notice clarifying the agency’s approach to determining the scope of orphan drug exclusivity. According to the FDA, it intends to continue applying its orphan drug regulations such that the scope of orphan drug exclusivity is tied to the specific orphan indication for which a drug is approved, not the indication for which it was designated. This approach, however, is in contrast with the 2021 Catalyst Pharmaceuticals Inc. v. Becerra ruling, and will likely position the agency for future challenges. The FDA’s approach also lends uncertainty to the ultimate scope of current and future periods of orphan drug exclusivity.