I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
Illinois has become the first state to enact restrictions on credit and debit card interchange fees – commonly known as swipe fees – linked to taxes and gratuities. The Interchange Fee Prohibition Act (the “Act”), embedded as...more
Over the past year, there have been numerous efforts by federal regulators - in particular the Consumer Financial Protection Bureau - to rein in "junk fees." The CFPB defines a "junk fee" to be an unnecessary and unavoidable...more
The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders. On September 22, 2023, the US...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-04, approving the per-booking fees healthcare providers pay a technology company for each new patient who...more
What are your fear factors when it comes to eDiscovery software? Is it predictability of costs? Pricing in general? How to reduce your monthly gigabytes? These are issues that come up regularly in the eDiscovery sphere –...more
Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more
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
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
The Biden Administration announced a crackdown on “junk fees” on October 26, led by the Consumer Financial Protection Bureau (CFPB) and the Federal Trade Commission (FTC), with the goal of “saving Americans, collectively,...more
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more
Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2023 fiscal year, which runs from October 1, 2022 through September 30, 2023. The FDA determined these rates pursuant to the Food and Drug...more
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
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On September 30, 2022, Congress enacted legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices, generic drugs and biosimilars (PDUFA,...more
Members of Congress, as usual, are racing to meet a deadline: This time, to determine the funding for the federal Food and Drug Administration, an agency with some of the most consequential responsibilities affecting...more
The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress. Key Points: ..Congress authorized FDA to...more
The 2022 Midterm Elections are a little over one month away and the races are tightening up. Democrats have seen their fortunes improve with a string of legislative victories and improving poll numbers for President Joe...more
The Food and Drug Administration’s (FDA) user fee programs, which pay the salaries of agency staff who review drug and medical device applications, are set to expire on October 1, 2022. These include the Prescription Drug...more
As September gets underway and Washington returns from a busy recess, important deadlines loom. August saw the introduction and passage of the Inflation Reduction Act, the Biden Administration’s announcement of student debt...more
Last week the Federal Trade Commission and six states sued rental listing platform Roomster, Corp. along with its owners for allegedly charging consumers for access to phony listings bolstered by fake reviews it had...more
With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more
Update on UFA Reauthorization Legislation - As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more
After weeks of bipartisan, bicameral negotiations on a legislative package to reauthorize FDA’s user fee programs, Senate Health, Education, Labor & Pensions (HELP) Committee Ranking Member Richard Burr (R-NC) withdrew from...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more
With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more