Features
Report Calls for Sweeping Changes At the FDA
In September, the Institute of Medicine of the National Academy of Sciences, a congressionally created entity dedicated to the study of policy matters pertaining to the public health, issued the results of the study of federal drug safety policy commissioned by the Food and Drug Administration (FDA). The resulting report, titled 'The Future of Drug Safety, Promoting and Protecting the Health of the Public' and published in the Archives of Internal Medicine, has been widely anticipated in light of recent publicity surrounding Vioxx' and other drugs that, subsequent to FDA-approval, proved more dangerous than thought.
Need Help?
- Prefer an IP authenticated environment? Request a transition or call 800-756-8993.
- Need other assistance? email Customer Service or call 1-877-256-2472.
MOST POPULAR STORIES
- Use of Deferred Prosecution Agreements In White Collar InvestigationsThis article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.Read More ›
- The DOJ's Corporate Enforcement Policy: One Year LaterThe DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.Read More ›
- The DOJ's New Parameters for Evaluating Corporate Compliance ProgramsThe parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.Read More ›
- China Finalizes New Regulations to Relax Personal Data Exports from ChinaNearly six months after the Cyberspace Administration of China (CAC) was first introduced for public consultation, the much-awaited final rules on Regulating and Facilitating Cross-border Data Flows were published and came into effect on March 22, 2024. The New Regulations largely repeat the Draft Regulations, but now have further relaxed personal data exports from China.Read More ›
- 10 Steps Legal Departments Should Be Taking to Prepare for the SEC's Newly Adopted Cybersecurity Risk Governance Rule for Public CompaniesBy readying your company's cybersecurity program now to comply with the SEC's cyber rules, you will also arm your company with a better defense against cyberthreat actors, reduce the reputational harm that comes along with a cybersecurity incident and increase investor confidence in the company's cybersecurity program.Read More ›
