Strategic Benefits of Consumer Surveys in Complex Litigation | Episode 69
Compliance Perspectives: Michael Horowitz, Inspector General at the Department of Justice, on Conducting High Profile Internal Investigations - Part 2
Compliance Perspectives: Michael Horowitz, Inspector General at the Department of Justice, on Conducting High Profile Internal Investigations - Part I
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more
On June 30, 2021, the House Committee on Appropriations (the “Committee”) issued a report accompanying a bill making appropriations for the U.S. Department of Agriculture, Food and Drug Administration (“FDA”), and related...more
On December 18, 2020, the Interagency Food Safety Analytics Collaboration (IFSAC) issued its 2018 Annual Report on the Sources of Foodborne Illness. The report collects and analyzes foodborne-illness outbreak data for...more
The cannabis world is abuzz with news about the latest federal Food & Drug Administration (FDA) report regarding cannabidiol (CBD). We break down what it is, and what it means for the industry and the regulatory landscape for...more
In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug...more
Product Recalls to Protect the Consumer? Is the Consumer Product Safety Commission, a federal agency charged with protecting the safety of Americans from dangerous and deadly items in the marketplace, doing its job? A...more
When reformers look for ways to slash the ever-higher costs of American medical care, one line item should leap from television screens, print pages, and radio broadcasts: How does the nation benefit from medical enterprises...more
In clinical research, compensating research subjects as an incentive for their participation is a common practice. However, paying research subjects can also pose ethical issues and create the potential for abuse such as...more
On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more
Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled...more
On May 19, 2015, FDA published in the Federal Register proposed a rule to collect antimicrobial sales and distribution data by major food animal species (cattle, swine, chickens, and turkeys). The purpose of the rule is to...more
Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more