The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aligos, Apollomics, Aquestive, Avrobio, Biomed Valley, Cipla, CSL, FSD, Gilead, Glaxosmithkline, Heron, Huya, Inceptua, Inovio, Khondrion, Orchard, Shionogi, Stemedica, Xcures.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alexion, Blueprint, Brickell, Cardiol, Daiichi, Eisai, Galapagos, Gilead, Kaken, Neurophth, Olix, Oncoheroes, Rakuten, Remegen, Spirovant, Vertex, Xiangxue.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaxis, Amicus, Anokion, Applied Therapeutics, Ascendis, Innova, Leap, Mereo, Telix.
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The latest global regulatory news, changes and updates affecting biopharma, including: Convalescent plasma trials expand; CBD public meeting, generics; ICER updates in CF in MM.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Cryosystem, Athenex, Athersys, Bluebird, Eagle, GW, Neurorx, Novartis, Pfizer, Sinovac, Symbio.
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
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