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Food and Drugs Law
United States
Foley & Lardner
Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a hearing aid.
Arnold & Porter
On July 25, 2022, the Food and Drug Administration (FDA or Agency) issued a proposed rule to amend the Agency's drug establishment registration and listing regulations...
Keller & Heckman
On August 16, a federal judge for the Northern District of Illinois granted WFM's motion to dismiss a proposed class action lawsuit that alleged WFM violated consumer protection statutes by selling its private label ...
Holland & Knight
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues
Arnold & Porter
Today, President Biden signed into law the Inflation Reduction Act (IRA). The IRA includes three primary drug pricing provisions that establish:
Akin Gump Strauss Hauer & Feld LLP
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 biologics...
Foley & Lardner
President Biden has now signed into law the $700 billion Inflation Reduction Act of 2022, a package comprised of health care, climate change, and taxation policy reforms.
Foley & Lardner
In an unprecedented move, the U.S. Food and Drug Administration (FDA or Agency) sent a warning letter to, Inc. (Amazon), a fulfillment house, with respect to distributing...
Keller & Heckman
A class-action lawsuit has alleged that Upfield US Inc. deceptively labeled its "Country Crock Plant Butter" as "Made with Almond Oil" and with images of almonds...
Keller & Heckman
FDA has made halting progress in establishing and implementing Standards for the Growing ...
Keller & Heckman
On August 10, 2022, FDA announced that it had issued a final guidance document for shell egg producers who provide laying hens with access to outside areas.
Keller & Heckman
The Center for Science in the Public Interest (CSPI), the Association of SNAP Nutrition Education Administrators (ASNNA), and the Association of State Public Health Nutritionists (ASPHN)...
Morrison & Foerster LLP
I was surprised to see that it just covers vaccines.
Harris Beach
The following is a summary of the federal Department of Health and Human Services' Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country.
On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022.
Goodwin Procter LLP
The legislation is expected to pass without modification by the House of Representatives and to be signed by President Biden shortly thereafter.
Oblon, McClelland, Maier & Neustadt, L.L.P
On July 11, Teva filed its petition for certiorari from the Federal Circuit's second decision in its "skinny label" litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022).
Keller & Heckman
Last month, the Court of Justice of the European Union (CJEU) confirmed that Member States may restrict or prohibit by law the cultivation of authorized Genetically Modified Organism...
Arnold & Porter
In March 2020, in response to the COVID-19 pandemic and associated health risks and travel restrictions, the Food and Drug Administration (FDA or the Agency) adjusted its field operations...
Duane Morris LLP
On July 28, the House of Representatives' Subcommittee on Biotechnology, Horticulture, and Research held a hearing to discuss ways in which the upcoming 2023 Farm Bill could improve...
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