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Feb 21, 2023 · Akebia says Peter Stein, M.D., director of the FDA’s Office of New Drugs, will now be the deciding authority for its appeal “due to agency resource constraints and staffing needs,” according ...
Peter Stein, MD. Deputy Director. Office of New Drugs / CDER / FDA. Disclaimers • Views expressed in this presentation are those of the speaker and do not necessarily
Jan 26, 2024 · The ISTAND pilot was designed to create a new pathway to FDA review for novel tools ... digital health technology project in neuroscience to be accepted into the pilot program,” Peter Stein, ...
Feb 21, 2023 · Drug candidate vadadustat’s pathway to US Food and Drug Administration (FDA) approval continues to encounter hurdles. Biopharmaceutical company Akebia Therapeutics announced today that their Formal Dispute Resolution Request regarding an FDA Complete Response Letter (CRL) for vadadustat’s application last year is now being reviewed by Peter Stein, MD, director of the Office of New Drugs at ...
Apr 12, 2018 · The FDA shows flexibility (described in a statute and regulations 3) in the design of programs for drugs targeting a serious or life-threatening disease, especially for rare diseases or uncommon ...
The approval of aducanumab is one of the most consequential and criticized decisions the FDA has made in years. The FDA advisory committee vote against approval was nearly unanimous, and the list price for the every-4-weeks maintenance dose of the drug is about $56 000 per patient per year. 1
Feb 21, 2023 · On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD).
