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First patch to the privacy laws in Australia: increased penalties for global companies

Increased penalties and wider application of the scope of the Privacy Act 1988 (Cth) (Privacy Act) come into effect shortly, with the Privacy Legislation Amendment (Enforcement and Other...

Insights and Analysis

Key issues for vertical agreements in the life sciences sector

This year has seen a number of significant changes to the EU and UK competition regimes, particularly in relation to vertical agreements. These changes have the potential to affect...


New FDA pilot offers expedited drug program sponsors expanded FDA meeting opportunities on manufacturing issues

Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and...


FDA invites comments on Expanded Access to Investigational Drugs guidance

The U.S. Food and Drug Administration (FDA) recently issued a revised version of the draft guidance “Expanded Access to Investigational Drugs for Treatment Use – Questions and...


Seeking harmony: FDA to align its human subject research regulations with Common Rule

Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal...


Spotlight on Greater China: out-licensing to Chinese counterparties

As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan ...


Inflation Reduction Act’s Medicare Part D benefit redesign explained

In the third of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Ken Choe and Melissa Bianchi discussed the Medicare Part D...


UK MHRA delays new medical devices legislation until July 2024

The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will...


U.S. Government seeks to restrict biotechnology cooperation with China

The United States government is increasingly scrutinizing U.S. industry’s reliance on China for biotechnology research and development and manufacturing, and is taking steps to expand ...

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