As I depart from the FDA today, I do so with great admiration and respect for the FDA organization and our 18,000+ talented workforce. It has been a true honor to have served as the 24th Commissioner of this incredible agency, and I will forever be grateful for the experience.
To our FDA staff, thank you for your dedication and resilience – and for always keeping science as your North Star in everything you do. I will be cheering you on as you continue to carry out the mission of the FDA.
These rules describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act.
Today, FDA finalized two foundational rules for premarket review of new tobacco products, w/ more information on minimum requirements for content, format and review of premarket tobacco product applications (PMTAs) & substantial equivalence (SE) reports. https://t.co/QT2kMrvmFG
The finalization of these rules is an important milestone in FDA’s regulation of tobacco products. The rules enable greater transparency & efficiency of FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the U.S.
Through partnership between the FDA, members of Operation Warp Speed, @CDCgov, and @USDA, data from 21 FORWARD is also being made available to assist states with their planning efforts for vaccine distribution.
FDA’s 21 FORWARD tool enables us to use CDC forecast data to track the incidence of #COVID19 across the country and identify areas in which its spread could impact key segments of the food system #FDAVoices https://t.co/ZgkzDm03lU
FDA is strongly committed to protecting public health based on good science. We’ve been open, transparent & believe these factors enhance America’s confidence in our independent judgements. We remain open to dialogues w/USG colleagues & all stakeholders on public health policies.
FDA does not support the Memorandum of Understanding that @HHSGov signed with @USDA announced today. FDA has no intention of abdicating our public health mandate. We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people.
FDA believes it is essential that any potential changes to the current regulatory framework be informed by public feedback and capture the agencies’ distinct missions with respect to animal and human health.
Together with CDRH Director Dr. Jeff Shuren, I wrote a piece highlighting significant diagnostic achievements over the last year: 300+ EUAs, that's nearly one test every day during this public health emergency. @FDADeviceInfo https://t.co/VivgZDrTar
Join FDA Commissioner @SteveFDA and Deputy Commissioner for Medical and Scientific Affairs @AnandShahFDA for their final episode of FDA Insight as they discuss FDA’s Pandemic Recovery and Preparedness Plan, or PREPP. https://t.co/yQ2FfaC9H7
This is an opportune time to engage in a public discussion regarding FDA as an independent agency. We have learned that the public has greater confidence when there are assurances that FDA’s actions are based on clearly based on independent evaluations of data and science.
This week I was asked about my thoughts regarding whether FDA would be better able to fulfill its mission if it were an independent agency. This discussion must carefully balance independence with appropriate oversight. https://t.co/oZYUstTQCP
Throughout the pandemic, FDA has maintained its commitment to protecting the public health based upon good science. We have been open and transparent. We believe these factors continue to enhance the American public’s confidence in the independence of FDA’s judgments.