News & Insights Search

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions to FDA.

PHILADELPHIA – Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased international collaboration is influencing the development of policies about artificial intelligence during the Drug Information Association's (DIA) Global Annual Meeting last week.

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

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was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.