Health Canada announces the forward regulatory plan 2023-2025: Regulations amending the Natural Health Products and the Food and Drug Regulations (Self-Care Framework)

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In September 2023, FDA released a final guidance entitled, “Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.” Under section 506B of the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70, drug and biologics sponsors must submit an annual report to FDA providing the description, schedule, and status of their postmarketing requirements and commitments (PMR and PMC). This final guidance, which closely mirrors FDA’s 2018 draft guidance document, outlines recommendations for completing and submitting reports – specifically, through Forms FDA 3988 and 3989 – which may relate to PMR/PMC studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology.

On September 18, 2023, FDA issued a draft guidance, titled, “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a combination product. FDA intends to consider several factors when determining whether the end-user output should be regulated as FDA-required labeling or promotional labeling. Factors include (1) whether the prescription drug use-related software provides a function that is essential to the safe and effective use of the product, (2) whether evidence is provided to support a clinical benefit when the prescription drug use-related software is used, and (3) whether the prescription drug use-related software relies on data directly transferred from the device constituent part of a combination product.