The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more
Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more
On January 1, 2023, the so-called Supply Chain Due Diligence Act (Lieferkettensorgfaltspflichtengesetz) (the “Act”) will go into effect in Germany. Many companies doing business in Germany will need to ready their compliance...more
9/9/2022
/ Corporate Governance ,
Corporate Social Responsibility ,
Due Diligence ,
Environmental Liability ,
Environmental Social & Governance (ESG) ,
EU ,
European Commission ,
Germany ,
Human Rights ,
Risk Management ,
Risk-Based Approaches ,
Supply Chain
On August 16, the President signed the Inflation Reduction Act of 2022 (IRA) into law. While this post focuses on key healthcare provisions in the IRA, the law likewise has significant implications for the energy sector and...more
On July 25, 2022, the Department of Health and Human Services issued a new proposed rule (subsequently published in the Federal Register on August 4) on Section 1557 of the Affordable Care Act (ACA), which prohibits...more
On July 22, the U.S. Food and Drug Administration released draft guidance entitled Conducting Remote Regulatory Assessments: Questions and Answers (FDA-2022-D-0810). A corresponding notice of availability was posted in the...more