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Food and Drugs Law
United States
In this post, we will provide an overview of the topics discussed at the Workshop and our impressions of the agency's likely next steps.
Alston & Bird
Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses.
Foley & Lardner
In response to President Biden's Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed...
Holland & Knight
In October 2021, the U.S. Food and Drug Administration issued a new draft guidance document concerning pharmaceutical compounding by hospitals and health systems.
Alston & Bird
Last week, the U.S.-EU Trade and Technology Council (TTC) held an inaugural meeting and discussed supply chain issues. The White House COVID-19 Response Team reported a decrease in case rates and hospitalizations.
Holland & Knight
The Medicaid regulations define "usual and customary price" as the price that pharmacy charges to the general public. 42 C.F.R. § 447.512(b).
Sheehan Phinney Bass & Green
On May 11, 2021, the United States Patent and Trademark Office (USPTO) issued its 11 millionth patent, which was directed to a method of delivering, positioning and/or repositioning a collapsible and expandable stent in a patient's heart chamber.
Holland & Knight
In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise
Alston & Bird
This week, the Department of Health and Human Services announced $100 million in American Rescue Plan funding for state programs supporting primary health care workers in underserved communities.
Michael Best & Friedrich
Wisconsin, along with California, Florida, and Utah, entered into mutual reliance agreements with FDA last week. These agreements are designed to foster federal and state cooperation and information...
Ford & Harrison LLP
While employers in the transportation industry are acutely aware of the effects COVID-19 has imposed over the last 18 months, another phenomenon has been making itself known...
Foley Hoag LLP
On October 13th our friends over at STAT broke the news [sorry, Paywall] about a "warranty" pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a refund ...
By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill...
Thompson Coburn LLP
As is evident from a walk down a grocery store aisle, many companies are marketing CBD-infused food, beverage, and dietary supplements.
Alston & Bird
Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs.
Akin Gump Strauss Hauer & Feld LLP
For several years, policy-makers and commentators have expressed concern about the resilience of the United States' pharmaceutical supply chain.
Foley & Lardner
The counterfeit business is booming. In fact, counterfeit goods account for a whopping 3.3% of global trade1 and cost the U.S. economy approximately $600 billion a year.2
Klein Moynihan Turco LLP
On October 7, 2021, California's Governor approved an amendment to AB-45 Industrial hemp products.
Cooley LLP
Using recent advances in cell culture technology, numerous companies are developing meat products produced in vitro using cultured cells derived from living animals.
Global Advertising Lawyers Alliance (GALA)
The vegan shoarma pizza is the latest addition to New York Pizza's pizza range. This launch did not go unnoticed, as is often the case with this pizza specialist. Earlier, we reported that the campaign promoting the...
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