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CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

News

USDA publishes final determination to declare Salmonella an adulterant in raw breaded and stuffed chicken products

On April 26, 2024, the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) announced its final determination to declare Salmonella an adulterant in...

News

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

News

DOJ enforcement of U.S. export controls compliance in context of anti-discrimination laws: 2024 update

Businesses working with U.S. export-controlled technology are subject to U.S. export control laws which impose restrictions on the release of such technology to certain foreign...

News

FTC disputes new slate of Orange Book patents for weight loss, diabetes, asthma, and COPD drugs

On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the...

News

Hong Kong Court of Appeal rules arbitration agreement trumps winding-up petition in insolvency

The Hong Kong Court of Appeal has finally laid to rest the vexed issue of whether an arbitration agreement or a winding-up petition should take precedence in an insolvency situation. In two ...

Insights and Analysis

ICC guidance should help the construction sector avoid and settle disputes

The ICC's recent proposals for resolving and settling disputes assist the construction industry, but parties still need to consider other strategies to manage construction and...

Insights and Analysis

Goodbye to the Net-Zero Insurance Alliance, welcome instead to the Forum for Insurance Transition to Net Zero

On 25 April 2024, the UN Environment Programme (UNEP) announced the creation of a new multi-stakeholder forum to support the insurance industry to accelerate and scale up the...

News

U.S. National Institute of Standards and Technology issues draft guidance on AI safety and standards

The U.S. National Institute of Standards and Technology (NIST) is seeking comment on four draft publications meant to promote safe, secure, and trustworthy artificial intelligence (AI)...

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