Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation.
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Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)).
Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform Technology Designation Program. Section 506K was established by Section 2503 of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act of 2022 and enacted as part of the 2023 Consolidated Appropriations Act.
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally.
The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin. In 2024, these quotas grew to 20,000 g and 24,000 g, respectively, from just 30 g and 50 g in 2020.
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program.
FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on November 22, which follows a proposed rule on the same topic published in 2010.
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition.
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.
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.