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Most companies treat the Form 483 response as the chance to close the loop after an FDA inspection. In many warning letters, FDA reaches a different conclusion: the company responded, FDA reviewed the response, and the agency still found the answer incomplete.

The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the committees saw a diminished role under previous FDA leadership.

Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of drugs and biologics; however, the commenters were split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The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market.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.