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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.

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.

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, the Trump administration is reviewing candidates for FDA commissioner, the agency is trying to repair relations with the rare disease community, and Vanda will have an opportunity to defend its jet lag drug at a public hearing next month.

The US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated risks. The agency also issued several warning letters to companies for violations of current good manufacturing practices (CGMP) and for marketing products for non-approved indications.

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, top FDA officials announced that the agency would require only a single pivotal trial for most drugs, the agency reversed course and said it would review Moderna's mRNA influenza vaccine, and FDA Commissioner Marty Makary said that most drugs should be available over-the-counter (OTC).

Pharmaceutical industry groups, drugmakers, and other industry stakeholders are pressuring the US Food and Drug Administration (FDA) to finalize its proposed rule to update the format of the National Drug Code (NDC) by the end of March 2026.

Stakeholders want the US Food and Drug Administration (FDA) to clarify and streamline regulatory requirements for sponsors of nonprescription over-the-counter (OTC) drugs. They also cautioned that the agency should avoid measures that could harm the generic drug industry, which could ultimately raise drug prices.

The US Food and Drug Administration (FDA) has finalized a guidance on how to conduct formal dispute resolutions (FDR) and administrative hearings to resolve scientific and/or medical disputes with sponsors of over-the-counter (OTC) drugs. The agency updated the draft version of the guidance to clarify limitations of the FDR process and ensure that requesters don't use multiple venues to address the same order.