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The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.

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.

Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.

The US Food and Drug Administration (FDA) on Thursday released its proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program, outlining its performance goals and program enhancements for the program for FY 2028-2032.

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

Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.

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.