FDA

As COVID restricts FDA travel, could its quality metrics proposal make a comeback?

After initially receiving negative feedback on its proposal to implement a quality metrics reporting program, the FDA’s proposed 2016 program could represent an effective means to getting around travel restrictions imposed by COVID-19.   By Aaron Badida, JD Background and Context The FDA regulates and inspects thousands of manufacturing, distribution, storage and dispensing facilities. While …

As COVID restricts FDA travel, could its quality metrics proposal make a comeback? Read More »

FDA inspections at record lows, reflecting impact of COVID-19

FDA data show that the agency conducted far fewer facility inspections in March 2020 than any other month in the last decade, reflecting the extent to which COVID-19 is impacting some routine regulatory activities.   By Alexander Gaffney, RAC and Kedest Tadesse, MS, RAC The number of FDA inspections of pharmaceutical and medical device firms …

FDA inspections at record lows, reflecting impact of COVID-19 Read More »

FDA releases long-awaited guidance on COVID-19 drug development

The guidance, intended to support companies racing to develop treatments for the novel coronavirus, outlines best practices for designing clinical trials that the FDA will consider sufficient to support approval. However, the guidance also notes several areas in which the agency is not yet providing recommendations, indicating that changes are yet to come. By Laura …

FDA releases long-awaited guidance on COVID-19 drug development Read More »

Congressional concerns about supply chain could create new requirements for FDA, industry

Three recently-introduced bills seek to study or transform the security of the US supply chain for pharmaceutical and biopharmaceutical products. AgencyIQ explains what they would do and their regulatory impacts.   By Aaron Badida, JD    Like many manufactured goods, the vast majority of common generic drugs and active pharmaceutical ingredients (APIs) in the US …

Congressional concerns about supply chain could create new requirements for FDA, industry Read More »

AgencyIQ Recap: New shortage requirements for devices; FDA’s evolving stance on diagnostics

Each week, the FDA publishes dozens of new policies, updates and regulations. POLITICO’s AgencyIQ analyzes these fast-moving, complex developments so you don’t have to. The following is a glimpse into what our research and news teams published this week. For more information on how you can become a subscriber of AgencyIQ and view all of …

AgencyIQ Recap: New shortage requirements for devices; FDA’s evolving stance on diagnostics Read More »

The Weekly Review

Welcome to The Weekly Review – a timely recap of AgencyIQ’s coverage of major life sciences regulatory trends and the biggest developments at FDA from the past week. It’s been an unsettling few days for much of the US as the realization dawns on many that things are about to become abnormal for a few months. During this uncertain time, we’ve been exploring how COVID-19 will affect FDA systems, processes, and regulatory approvals. We’ve also been covering profound developments related to the VALID Act, FDA’s new diabetes drug development guidance, and companies’ response to shifting drug importation policy.

Seven Regulatory Problems Laid Bare by the Coronavirus

Few things expose regulatory fault lines quite like an international medical emergency. For the Food and Drug Administration, the novel coronavirus (SARS-CoV-2) outbreak has exposed several longstanding regulatory issues that could have the potential to substantially impact how the US is able to effectively respond to not only this outbreak, but future emerging threats.