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Food and Drug Administration (FDA) › Australia

Knobbe Martens

UK Proposes Approving Medical Devices Based on Approval in Other Countries

Knobbe Martens on

Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom.  On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more

Vicente LLP

A Wake-up Call from Down Under: Australia's Therapeutic Goods Administration Reschedules Psilocybin and MDMA

Vicente LLP on

As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug...more

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Searcy Denney Scarola Barnhart & Shipley

Is Rapid Really a Good Thing? — FDA-Approved Over-the-Counter COVID-19 Test Recalled

Searcy Denney Scarola Barnhart & Shipley on

Over 400,000 COVID-19 rapid test kits have been recalled by Australian manufacturer Ellume. The reason? Way too many false positive results. “At Ellume, we understand that trust is central to fulfilling our purpose...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l November 2019 #2

Shook, Hardy & Bacon L.L.P. on

LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more

Smart & Biggar

Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

Smart & Biggar on

On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

Jones Day

United States and Australia: Comparable Food Safety Systems

Jones Day on

On April 19, 2017, FDA announced that both the United States and Australia have recognized each other's food safety systems as comparable to each other. This is the third time that the FDA has given this recognition to a...more

Jones Day

Food, Dietary Supplement & Cosmetics Regulatory Update Vol. IV | Issue 4

Jones Day on

On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

K&L Gates LLP on

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

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