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November 7, 2023
Real-Time Oncology Review (RTOR) Draft Guidance for Industry
April 26, 2023
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle...
April 21, 2023
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle...
April 11, 2023
On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas)...
March 30, 2023
Center for Biologics Evaluation and Research CBER at Food and Drug Administration FDA published first untitled letter of the year to Thomas Advanced Medical LLC for marketing human cells, tissues, or cellular or tissue-based products HCT/Ps without FDA premarket review.
March 30, 2023
On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas...
February 2, 2023
Enacted on December 29, 2022, the Consolidated Appropriations Act (the year-end omnibus spending bill) includes the Food and Drug Omnibus Reform Act (FDORA)...
October 11, 2022
Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the...
October 6, 2022
Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the...
May 11, 2022
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user...