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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.

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

The US Food and Drug Administration (FDA) recently posted four warning letters to pharmaceutical manufacturers in the US, Canada, and China for violations of current good manufacturing practices (CGMPs) and for marketing unapproved drug products.

The US Food and Drug Administration (FDA) on Tuesday reprimanded a US manufacturer and contract testing lab, BRS Analytical Services, for producing eye drops under unsanitary conditions, and an Australian company, Melcare, for making unapproved drug claims regarding their eye drops.

PITTSBURGH — US Food and Drug Administration (FDA) officials invited industry to discuss options for using a new approval pathway that broadens consumer access to nonprescription drugs and offered tips for potential applicants during a 9 October session at RAPS Convergence 2025.

The World Health Organization (WHO) issued an alert on Monday identifying oral cough syrups manufactured in India that contain diethylene glycol (DEG), a substance typically used as an industrial solvent and in antifreeze. According to the BBC, at least 20 children in India have died after ingesting these cough syrups.

The US Food and Drug Administration (FDA) recently issued warning letters to three domestic companies for multiple violations of good manufacturing practices (GMPs) in their production of over-the-counter drugs. The warning letters cited several common issues, including the companies' failure to conduct adequate testing of incoming components and ensuring that their manufacturing processes were in a state of control.

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the federal government. During the funding lapse, FDA said it will not accept any regulatory submissions that require a fee.

The US Food and Drug Administration (FDA) recently warned two drug makers and a drug testing lab for current good manufacturing practices (CGMP) violations, such as marketing products after detecting microbes and particles. It has also cited half a dozen online retailers for selling unapproved eye drops.

Pharmaceutical companies in the US are requesting additional information on how to conduct stability testing for both new and existing drugs in response to the International Council for Harmonisation's (ICH) recent Q1 guideline. They have raised questions regarding the scope of the guideline and the appropriate timing for stability testing of drugs in development.

This is what six regulatory affairs professionals learned from their experience at the RAPS Kellogg Executive Development Program.

The Food and Drug Administration (FDA) has released draft guidance and a proposed administrative order regarding the documentation required for minor dosage form changes in over-the-counter (OTC) monograph drugs that are highly soluble and highly permeable. Additionally, the FDA has issued a second administrative order mandating that certain OTC monograph drugs be packaged in single-dose or unit-dose containers.

The US Food and Drug Administration (FDA) has released six warning letters to companies in China, India, Malaysia, and France for significant violations of good manufacturing practice (GMP) regulations for finished pharmaceuticals. Among other problems, the letters flag customer complaints about moldy products, unsanitary manufacturing conditions, and lax testing processes.