10 For 10: Top Compliance Stories For the Week Ending May 10, 2025
AGG Talks: Cross-Border Business — Episode 7: Trans-Pacific Business: Australia and the U.S. - Part 2
AGG Talks: Cross-Border Business — Episode 7: Trans-Pacific Business: Australia and the U.S. - Part 1
Season 2 Episode 5- Defense Trade Down Under
Patent Grace Period Considerations in Australia, Japan, South East Asia and the U.S.
JONES DAY PRESENTS®: The Future of Transfer Pricing in Australia: Implications of the Glencore Decision
Jones Day Talks: Doing Deals Down Under: Australia's Foreign Direct Investment Regime
What is the Current State of Anti-Bribery Compliance & Enforcement in Australia?
Front-Line Video: An Interview with Jane Ellis, Anti-Bribery and Compliance Expert
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
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
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
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
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
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
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
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
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
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