Regulatory Focus

Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry offers improvements over the current program while addressing the agency’s resource constraints.

The US Food and Drug Administration (FDA) recently issued two warning letters to a sterile drug manufacturer and an over-the-counter (OTC) drug maker in the US for multiple violations of good manufacturing practices (GMPs). These violations included inadequate contamination controls, failure to investigate batch issues, and insufficient testing of components.

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

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.