Regulatory Blog

Bioequivalence (BE) plays a critical role in generic drug development by demonstrating that a generic product performs similarly to its reference listed drug (RLD). To support approval of an Abbreviated New Drug Application (ANDA), manufacturers must establish that the proposed generic product delivers a comparable rate and extent of drug absorption under similar conditions of use. The FDA’s updated guidances, Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Su

Human factors engineering focuses on understanding how users interact with medical devices and applying that knowledge to design safer and more effective products. The FDA explains that user interface design can significantly impact patient safety, as user errors may lead to incorrect treatment, delayed therapy, compromised medical care, or patient harm. Manufacturers routinely perform human factors assessments during device development to identify and mitigate use-related ri

In May 2026, the FDA Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) issued the draft guidance Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products. The guidance introduces risk-based approaches for nonclinical safety assessments of certain oncology biologics and conjugated products, aiming to facilitate development while maintaining patient safety. The guidance highlights that data anal