FDA publish guidance on bioequivalence studies that have been impacted by COVID-19

Acknowledging the disruption to bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs) caused by the COVID-19 pandemic, the US Food and Drug Administration (FDA) has provided details on how sponsors should manage the situation. Read more “FDA publish guidance on bioequivalence studies that have been impacted by COVID-19”

US FDA exempt certain medical devices from premarket notification requirements as part of their COVID-19 response

With the unprecedented COVID-19 public health emergency leading to an unforeseen demand for certain medical devices, the US Food and Drug Administration (FDA) has published a notice exempting these devices from 510(k) premarket review requirements. Read more “US FDA exempt certain medical devices from premarket notification requirements as part of their COVID-19 response”

FDA details regulatory framework for AI/ML-Based Software as a Medical Device

In April 2019, the US Food and Drug Administration (FDA) published a discussion paper and request for feedback regarding their proposed regulatory framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Following feedback from the industry, the FDA has now published a five part action plan. Read more “FDA details regulatory framework for AI/ML-Based Software as a Medical Device”

The FDA details their plans to advance regulatory science in 2021

The US Food and Drug Administration (FDA) have released a report on their Focus Areas of Regulatory Science (FARS) for 2021. This document aims to “identify and communicate priority areas where new or enhanced investments in regulatory science research capacity are essential to support FDA’s regulatory and public health mission”. Read more “The FDA details their plans to advance regulatory science in 2021”

The FDA published their final guidance on consultation for combination products

In the US, a combination product is defined as “a product comprised of any combination of a drug, device, and/or biological product.” They are assigned to a lead FDA agency based on the component providing the primary mode of action. This agency will regulate the premarket and postmarket activities. Read more “The FDA published their final guidance on consultation for combination products”