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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. A key Senate committee will consider several important pieces of legislation that affect the healthcare products industry next week, FDA has approved a new sunscreen for the US market, and the agency published several guidances, including one on developing human genome editing products.

As cell and gene therapies (CGTs) continue to advance, they have unique developmental features that may require innovation in a clinical trial setting, the authors of a recent paper explained.

BALTIMORE – Experts who spoke at the RAPS Quality Conference on Wednesday said that a successful quality culture must come from the top and be continuously reevaluated. They added that employees need to feel empowered to ask questions and trust that their company is transparent with them.

Researchers from the European Medicines Agency (EMA) have published a paper on regulatory research priorities for AI across the medicine lifecycle.

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

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top agency official. She emphasized that companies need to treat risk management as an ever-evolving responsibility.

A recent report from the US Pharmacopeia (USP) reveals that drug shortages decreased by 23% in 2025; however, the duration of shortages is on the rise. Over 64% of the drugs that are currently in shortage have been unavailable for more than three years, and 39% have been in shortage for over five years.

Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.

Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.

BALTIMORE – Kerri DiPietro, chief quality officer at Integra LifeSciences, said that drug and device makers need to be methodical and purposeful when considering elevating their companies' quality cultures. She noted that it involves getting buy-in from key leadership, measuring the progress, and implementing a plan that may take years to accomplish.