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The International Medical Device Regulators Forum (IMDRF) has finalized a technical document outlining how regulatory agencies may adopt predetermined change control plans (PCCP). The document lists principles for regulators to consider when developing their own PCCP regulations, as well as key elements to include in manufacturers' PCCPs.

The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified logbooks to the agency. The agency also warned two other OTC firms for multiple violations of good manufacturing practice (GMP), including testing violations.

The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.

US Food and Drug Administration (FDA) officials said the next iteration of the Medical Device User Fee Amendments (MDUFA VI) will focus on improvements in consistency during the review process and promoting domestic priorities, rather than pursuing shorter review timelines compared to MDUFA V.

The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation Network (QMIN), a cross-sector platform that uses quantitative medicine approaches to accelerate drug development and regulatory science and improve clinical decision-making.

Two recent papers published in JAMA have highlighted the potential need for additional regulatory scrutiny for low-risk digital health technologies used by consumers.

The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS products and a draft guidance on assessing skin irritation using in vivo studies in TDS products.

A proposed amendment to 21 CFR Part 207 that eases registration rules for distributed manufacturers by allowing them to register as a single establishment could lead to a new paradigm where manufacturers shift their focus from product development to ensuring a product remains the same across multiple manufacturing sites.

The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products, such as prefilled syringes and autoinjectable pens.

The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends.