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May 17, 2023
Over the past several years Congress has tried to address high drug prices, with variable success  (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More...
February 23, 2023
Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by...
January 30, 2023
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...
January 30, 2023
On January 24, 2023, the Food and Drug Administration published a notice in the Federal Register to “address the uncertainty” created by the US Court of Appeals for the Eleventh...
January 16, 2023
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over...
January 10, 2023
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (H.R. 2617), an omnibus appropriations bill to fund the U.S…
January 10, 2023
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (H.R. 2617), an omnibus appropriations bill to fund the U.S. government for fiscal year 2023.
January 10, 2023
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s...
May 12, 2022
/PRNewswire/ -- The National Organization for Rare Disorders (NORD) applauds efforts of Congressional leaders to protect the Orphan Drug Act (ODA) and ensure...
May 11, 2022
WASHINGTON, D.C. – Today, U.S. Senators Tammy Baldwin (D-WI) and Bill Cassidy, M.D. (R-LA) introduced bipartisan legislation, the Retaining Access and Resto