The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal...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
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION - The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare...more
Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more
Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that...more