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The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market.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.

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.

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.

CHARLOTTE, NC — Whether the US Food and Drug Administration (FDA) will accept clinical evidence from outside the United States (OUS) depends on if the investigations followed good clinical practice (CGP) regulations, but the data should also be applicable for regulatory purposes.

Heidi Overton, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), faced questions from both sides of the political aisle about her views on hot-button issues facing the agency during a Senate confirmation hearing on Thursday.

Pharmaceutical industry groups largely support the US Food and Drug Administration’s (FDA) proposed rule on distributed manufacturing but are seeking clarification on how the proposed model would function and specific changes they say would make it easier to implement distributed manufacturing models.

CHARLOTTE, NC — While new approach methodologies (NAM) offer a path to reduced reliance on animal testing, experts say global regulators need to agree on their use to give sponsors predictability and regulatory assurance.

CHARLOTTE, NC — Officials from the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and other European regulators said that successful meetings with sponsor involved transparency, open collaboration, listening, early communication, and having sufficient data to answer questions.