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Legal Risk Management Forum: panel highlights
In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more
True to its word, the SEC released its proposed rule, The Enhancement and Standardization of Climate-Related Disclosures for Investors, last week. The rule would require companies to disclose a wide variety of climate-related...more
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
The Modern Slavery Act (“MSA”) was introduced in the United Kingdom in October 2015 introducing criminal offences of slavery, servitude, forced or compulsory labour and human trafficking. However, its most profound impact has...more
Massive automotive recalls continue to grab headlines and raise concerns industry-wide. Recalls of light vehicles topped 50 million units in 2016, representing the third consecutive year of elevated – and record setting –...more
The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more