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Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of drugs and biologics; however, the commenters were split over how flexible the agency should be in its approach and asked for additional clarity

The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market. It includes non-clinical and clinical testing requirements that sponsors should include in their premarket submissions.

CHARLOTTE, NC – A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help sponsors bring products to market more streamlined and predictably.

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

The US Food and Drug Administration (FDA) has published its proposed commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, outlining several notable departures from the current biosimilar review program. FDA said the changes are intended to streamline biosimilar application reviews and enhance regulatory efficiency.

CHARLOTTE, NC — When submitting a biologics license application (BLA), it is important to engage with the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) early, make every attempt to prepare for and prevent technical and administrative errors, and keep the regulatory project manager (RPM) in the loop during the process.

The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation.

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

Michael Davis, the director of the FDA's Center for Drug Evaluation and Research (CDER), stated that increasing the availability of generic versions of glucagon-like peptide-1 (GLP-1) medications is a top priority for the agency to lower costs for Americans.