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Drug, regulatory, and laboratory animal testing groups want the US Food and Drug Administration (FDA) to ensure flexibility in choosing when to rely on animal testing and when other forms of data may be sufficient for cancer drug safety studies.

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

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

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 leaders spelled out the case for an upcoming overhaul of the agency’s inspectional operations, the agency’s top biologics regulator proposed steps to make the US more attractive for early stage research, and the agency approved a controversial cancer drug after twice rejecting it.

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

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

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

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The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable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