On July 23, 2025, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) to gather information and data to help establish a federally recognized...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
As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps...more
California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...more
Following nearly a year of committee hearings, research, policy briefs, and discussion with agency experts, the Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member...more
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
On April 23, 2020, the House of Representatives passed the Paycheck Protection Program and Health Care Enhancement Act, which previously passed the Senate on April 21, 2020, and is expected to be signed into law by the...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more