On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more
1/10/2023
/ Abbreviated New Drug Application (ANDA) ,
Animal Testing ,
Budgets ,
Clinical Trials ,
Consolidated Appropriations Act (CAA) ,
Cosmetics ,
Counterfeiting ,
Diversity and Inclusion Standards (D&I) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
New Amendments ,
Purple Book ,
User Fees
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
10/11/2022
/ 21st Century Cures Act ,
510(k) RTA ,
Biomedical Advanced Research and Development Authority (BARDA) ,
CDS ,
Coronavirus/COVID-19 ,
Dietary Guidelines ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
FDA De Novo Clearance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Proposed Rules ,
Public Health ,
Software ,
User Fees ,
Virus Testing
Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
1/22/2018
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Competition ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Notice Requirements ,
Orange Book ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
User Fees
As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more
It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act...more
On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more
Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more
5/5/2017
/ Biosimilars ,
BsUFA ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
PDUFA ,
Prescription Drugs ,
Proposed Legislation ,
User Fees
On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more
4/19/2017
/ Biosimilars ,
FDA Reauthorization Act ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Legislative Agendas ,
Medical Devices ,
Prescription Drugs ,
Public Hearing ,
Reauthorization ,
User Fees
As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more
In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series...more
Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the...more