During this exclusive on-the-record briefing for reporters, Robert M. Califf, M.D., Commissioner of Food and Drugs for the U.S. Food and Drug Administration, participated in a fireside chat with Sarah J. Dash, President and CEO of the Alliance for Health Policy, and respond to audience questions.
The Food and Drug Administration (FDA) was first authorized to collect user fees in 1992 under The Prescription Drug User Fee Act to provide funding to the agency during a period of federal budget cuts. Over the past 30 years, user fee programs have helped finance the FDA’s review of human medical products such as drugs and medical devices.
This event explained user fee programs and their role within the drug development and FDA regulatory review process. Panelists provided insights on the stakeholders, timeline, the process of reauthorization, the history of these bills being used for broader health legislative initiatives, and explored lessons learned.
This briefing will overview what rare diseases are and how we classify them, what populations rare diseases impact, and will focus on the challenges and potential solutions to better improve the diagnostic odyssey.
This briefing will clarify the defining characteristics of Medicare Part D including eligibility, coverage, and benefits. Attendees will understand the case for Medicare Part D redesign and the implications and tradeoffs of current policy options on beneficiaries and other stakeholders.
Attendees learned the challenges and opportunities states face in safe and timely vaccine deployment and supply management, plans states are executing to ensure equitable vaccine distribution, and plans states are executing to ensure equitable vaccine distribution along the way.
This briefing explored the current state of COVID-19 vaccine deployment efforts, cultural, historical, and political influences that may generate feelings of hesitancy, and how to ensure optimal vaccine uptake in key populations.
This briefing explored how our supply chain must respond to manufacture millions of doses and then swiftly deliver them to administration sites. Panelists also illustrated the steps these stakeholders might take in the first 48 hours after an Emergency Use Authorization is approved.
This discussion focused on measures industry stakeholders have taken for safe COVID-19 vaccine deployment and the immediate steps these stakeholders will take in the first 48 hours after the Emergency Use Authorization was approved.
During this on-the-record briefing for reporters, Admiral Brett P. Giroir, M.D., Assistant Secretary for Health at the U.S. Department of Health and Human Services, provided opening remarks and responded to questions from reporters.
During this on-the-record briefing for reporters, Joe Grogan, Assistant to the President and Director of the Domestic Policy Council provided opening remarks and responded to questions from reporters. The question and answer period was moderated by William Pierce, Senior Director, APCO Worldwide.
During this congressional lunch briefing, analysts will outline the mechanisms of the Medicare Part D program under current law and discuss the potential implications of reforms put forward by Congress and the administration.
During this briefing, panelists explained the mechanisms of biologic drugs, explore the impact of current regulations on the uptake of biosimilars, and discuss considerations for the biosimilars market in the United States.
This webinar will focus on the first approach and will explore different perspectives on how increasing the number of generic and biosimilar options may affect the drug pricing market. Specifically, panelists discussed the main opportunities and challenges of the generic and biosimilar market, how past administrations have approached this issue, and how different stakeholders, including consumers, are impacted.
The purpose of this briefing was to orient federal policymakers and stakeholders to the legislative and regulatory actions that state officials are perusing to address the rising cost of prescription drugs in Medicaid. Panelists outlined the rationale for these actions, detailed the mechanisms of state policies, and described opportunities to leverage flexibility within federal parameters.