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Small Business Food and Drug Administration (FDA)

Hogan Lovells

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

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On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

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The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Jenner & Block

Government Contracts Legal Round-Up – 2024 Issue 12

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Claims Updates - Associated Energy Group, LLC v. The United States and Kropp Holdings, Inc., No. 23-20 47 (July 2, 2024) - Associated Energy Group, LLC (AEG) challenged the award by Defense Logistics Agency (DLA) for a...more

Saul Ewing LLP

Delaware Regulators Issue First Set of Draft Adult-Use Marijuana Regulations

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On February 14, 2024, the Delaware Office of Marijuana Control (OMC) released draft regulations for the state’s adult-use cannabis market. Public comment is due on or before March 29, 2024. These regulations include the rules...more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the...

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and Genevieve M. Razick, an attorney in our Healthcare and Food & Drug practices, along with Leah D. Braukman, an attorney in our Corporate & Finance practice,...more

Partridge Snow & Hahn LLP

Congress Keeps Taking Baby Steps on Marijuana Reform

This month, two congressional Republican lawmakers introduced a bill to legalize marijuana at the federal level, as well as to protect banks that service state-legal cannabis businesses and to ensure that military veterans...more

Perkins Coie

The Food & Beverage Industry and the COVID-19 Pandemic

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The global pandemic has affected not only how individuals work but also the way companies supply food, how consumers shop, and how regulators try to alleviate food shortages during the pandemic. Here are some of the biggest...more

Pillsbury Winthrop Shaw Pittman LLP

What Will the Biden/Harris COVID-19 Plan Mean for Business?

The incoming Biden Administration promises a more nationalized approach to combatting the COVID-19 public health crisis, plus a large economic stimulus response focused on unemployment, paid leave, state and local government...more

Womble Bond Dickinson

Let the record reflect –Are you keeping the records required by the FSMA Produce Safety Rule?

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As part of the Food Safety Modernization Act (FSMA), the Produce Safety Rule outlines the regulatory requirements that apply to entities that grow, harvest, pack or hold fresh produce. Depending upon the amount of their...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 14

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In Washington - Treasury Secretary Steven Mnuchin said Thursday that he and House Speaker Nancy Pelosi (D-CA) have agreed to revive negotiations over a stalled follow-up coronavirus relief bill. Speaker Pelosi has...more

Moritt Hock & Hamroff LLP

Protecting Your Business When Entering Into A PPE Agreement

Although many businesses throughout the United States were decimated during the Covid-19 pandemic, a few have been able to pivot and take advantage of new opportunities unfolding in the now lucrative market for personal...more

Hudson Cook, LLP

AFSA Extra Credit Podcast: Navigating Advertising During COVID-19

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Advertising during a global pandemic and social justice movement triggers an increased level of regulatory risk and reputational harm. Regulators moved quickly to interrupt bad actors that took immediate advantage of...more

Hogan Lovells

FDA Announces Inspections of Small Businesses under FSMA Intentional Adulteration Rule to Begin March 2021

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The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Update #21

Leaders of Small Business Committee Reach Consensus on Bill to Extend PPP Loan Deadline, Senate Fails to Clear Measure by Unanimous Consent as Phase 4 Negotiations Likely to Dominate June - Bipartisan leaders of the Senate...more

Mintz - ML Strategies

COVID-19 Insights Week In Review — April 8, 2020

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As the coronavirus pandemic spreads across the nation, your team at ML Strategies continues to monitor legislative and regulatory updates at the federal and state level. Each week, ML Strategies will provide weekly updates...more

Faegre Drinker Biddle & Reath LLP

FDA Helps the Food Supply Chain by Easing Labeling Requirements During the COVID-19 Pandemic

On March 26, 2020, the Food and Drug Administration (FDA) issued Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency to provide restaurants...more

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

Hogan Lovells

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive...

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The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more

PilieroMazza PLLC

Weekly Update Newsletter - May 2019 #3

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FALSE CLAIMS ACT / LITIGATION - U.S. Supreme Court – According to Law360, the U.S. Supreme Court ruled unanimously that the “government knowledge” statute of limitations applies in False Claims Act cases regardless of...more

Robins Kaplan LLP

Your Daily Dose of Financial News

Robins Kaplan LLP on

CEO Dara Khosrowshahi is undoubtedly breathing a sigh of relief on news out of the UK yesterday that Uber will regain its taxi license in London—a “crucial victory for efforts by its new chief executive to revamp the...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2017 #3

As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more

Arnall Golden Gregory LLP

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

McDermott Will & Schulte

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Holland & Knight LLP

Food and Beverage Law Update: October 2015

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Labor and Employment - Plaintiff Wage and Hour Lawsuits Continue to Climb - Wage and hour litigation has become what some call the new "workplace revolution." Data from the Federal Judicial Center indicates that...more

Knobbe Martens

FDA Announces 2016 Medical Device Fees

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The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more

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