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The US Food and Drug Administration (FDA) has issued warning letters to several drugmakers for violations of current good manufacturing practices (CGMP). The agency also issued a warning letter to a Chinese drugmaker for marketing drugs in the US without providing regulators with the critical records needed to ensure compliance.

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

Officials from the US Food and Drug Administration (FDA) and pharmaceutical industry representatives could not reach an agreement on the number of reference product exclusions (RPE) to make each year, and agreed to table the issue until another meeting, according to the minutes from a recent discussion on reauthorizing the Biosimilar User Fee Act (BsUFA).

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 HHS proposed several big measures to accelerate drug development, FDA warned about third-party testing facilities falsifying drug data, and the agency published several reports on the state of the drug industry and clinical trials.

The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that the lack of details about the drug's full indication and limitations, especially insufficient statements about its risks, could mislead healthcare providers.

The US Food and Drug Administration (FDA) roadmap to reduce animal testing as a requirement for drug development has already made an impact after its first year, but the initiative faces future challenges in scaling and international harmonization, a group of experts wrote in a recent paper published in Stem Cell Research & Therapy.

Several industry groups and drugmakers have written to the US Food and Drug Administration (FDA) to ask the agency to harmonize its recent draft guidance on developing fermentation and semi-synthetic antibiotics with global regulators. They also said the guidance lacked significant detail and asked the agency to harmonize terminologies.

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was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