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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 the appointment of Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER) and the House Appropriations committee advanced a bill to fund FDA in FY 2027.

WASHINGTON – US Food and Drug Administration Commissioner Marty Makary said the agency should apply the same urgency as it did to approve the first treatments for HIV/AIDS in the 1990s to new drugs and medical devices, including those for Alzheimer’s disease, Type 1 diabetes, and cancer.

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for noncompliance with current good manufacturing practices (cGMPs). Additionally, FDA sent an untitled letter was to Incyte for making misleading claims about a product on its website.

New clinical trial regulations came into force in the UK this week, marking the biggest change in the law on running human studies in the country in more than 20 years.

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

COLUMBUS, OH – The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and provided an update on several ongoing initiatives at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

WHITE OAK, MD – The US Food and Drug Administration (FDA) has announced plans for a future pilot program intended to facilitate the real-time review of clinical trials by regulators, as well as the launch of two proof-of-concept studies that will gather and report endpoints and other signals to regulators in real time.

COLUMBUS, OH – The US Food and Drug Administration (FDA) and representatives from industry have reached an agreement in principle on negotiations for reauthorization of the Medical Device User Fee Amendments (MDUFA VI) program, an FDA official told attendees at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Fewer than half of the studies funded by the US National Institutes of Health (NIH) examined sex differences, despite a 2016 policy requiring grantees to report on them, according to a study published in Nature Communications Medicine.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of the biggest changes, officials said, is that risk is at the center of quality processes