Laura DiAngelo

1 month ago | agencyiq.com | Alexander Gaffney |Laura DiAngelo

Life Sciences | By Alexander Gaffney, MS, RAC, Laura DiAngelo, MPH AgencyIQ has identified 17 executive orders, policies, legislative initiatives, and scenarios that have already, or will likely soon, negatively impact FDA’s employment figures.

Nov 6, 2024 | agencyiq.com | Alexander Gaffney |Laura DiAngelo |Rachel Coe

The election of DONALD TRUMP as the next President of the United States is likely to have major impacts on the FDA and the life sciences industry. In this ongoing series of explanatory analyses, AgencyIQ answers some of the most common questions from our subscribers about what Trump and a newly elected Congress could mean for the FDA and specific areas of regulation. What does Trump’s election mean for the reauthorization of FDA’s user fee programs?

Jun 27, 2024 | friendsofcancerresearch.org | Laura DiAngelo

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Jun 26, 2024 | friendsofcancerresearch.org | Laura DiAngelo

Quick background: FDA’s work to advance clinical trial diversity through prospective planningThe FDA has longstanding policy interests focused on research study diversity. The agency first issued guidance on demographic subgroup analyses in the 1980s. In the intervening years, FDA continued to update guidance in line with updates from the Office of Management and Budget (OMB) and Congressional directives.

Feb 1, 2024 | friendsofcancerresearch.org | Laura DiAngelo

The in vitro diagnostics (IVD) down-classification initiativeA quick background on medical device regulation: In vitro diagnostics (IVDs) are regulated by the FDA as medical devices – meaning that tests and diagnostics typically go through the medical device market access pathways and comply with post-market regulations (e.g., quality system requirements).