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The US Food and Drug Administration (FDA) on Monday released final guidance detailing the procedures for holding formal meetings between sponsors of over-the-counter (OTC) monograph drugs and the agency. This update revises the criteria for the types of meetings that sponsors can request and introduces hybrid meetings as an additional option for consultations with FDA.

The US Food and Drug Administration (FDA) has finalized its guidance on clinical trial requirements for developing psychedelic therapies. The final version clarifies the agency's thinking, based on industry feedback, especially regarding clinical and safety considerations in the design of clinical trials.

India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological products as part of a recent revision to the country’s drug pricing legislation.

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

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, there were reports that the Trump Administration is reviewing candidates to head FDA, FDA was pressured to pause publishing complete response letters (CRL), and more.

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing methods and increase supply chain visibility. In a proposed rule, the agency said it will enable distributed manufacturers to register as a single entity under a “hub-and-spoke” model and clarified when foreign establishments must register as a manufacturer.

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices without authorization, including devices for eyelid cleaning and an infection control system. Additionally, the agency sent an untitled letter to a company regarding misleading promotional communications for a prescription migraine drug.

Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found that the potential leaching of metals from tampon usage in even the most conservative conditions was negligible.

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

A Council of Europe committee has warned that “an overly expansive interpretation” of the Medical Device Regulation (MDR) could undermine access to therapies based on human blood, tissues, and cells.