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The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was proposed. Among the updates is  a new section on evaluating drug effects across multiple diseases, conditions, or disease subtypes in basket trials.

PHILADELPHIA – Peter Stein, the former head of the US Food and Drug Administration’s Office of New Drugs (OND), criticized the agency’s Commissioner’s National Priority Voucher Program (CNPV) and its one- to two-month review timeline, saying it’s almost “an insult to the FDA reviewers.”

Among oncology drugs first approved by the US Food and Drug Administration, other regulatory authorities varied in how they approved the same products, both in terms of the regulatory frameworks and the evidentiary thresholds used as the basis for the approvals, according to recent research published in Frontiers in Pharmacology.

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 new partnerships with two international regulators and reversed two notable decisions made under former top officials.

The European Commission has adopted new harmonized standards for medical devices and diagnostics but established a five-year transition period to give manufacturers time to adapt their processes.

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

Philadelphia – Officials from the US Food and Drug Administration (FDA) discussed strategies for integrating artificial intelligence (AI) with real-world evidence (RWE) to advance drug development during a panel discussion at the DIA Global Annual Meeting on Tuesday. The officials noted there have been an increasing number of submissions that utilize both AI and RWE.

The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to meet quality system and current good manufacturing practice (CGMP) requirements. The agency has also cited more than two dozen telehealth companies for marketing compounded glucagon-like peptide-1 (GLP-1) receptor agonist drugs without authorization.