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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA announced a major reorganization intended to streamline operations, and the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTAGTAC) met this week to vote on whether to recommend therapies for Duchenne muscular dystrophy and melanoma.

The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable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.

Most adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than accelerated approvals, according to a study published in JAMA on Thursday.

The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide products. These PSGs focus on peptide drugs used to treat conditions such as obesity, type 2 diabetes, osteoporosis, and macular degeneration.

EFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Industry stakeholders have asked the US Food and Drug Administration (FDA) to provide more clarity in a recent draft guidance aimed at helping sponsors determine dose selections using a quantitative systems pharmacology (QSP) approach for first-in-human (FIH) dose in phase 1 trials.  Additionally, they want FDA to provide more regulatory flexibility in changing dose selection, especially during early phases, and harmonize with international standards.

The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for transitional listed status. Following evaluations, these authorities may transition to formal WHO-listed authorities (WLAs).