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.
BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
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.”
According to the Swiss association for medical technology companies, Swiss Medtech, introducing the new European regulations for medical devices (MDR) and in vitro diagnostics (IVDR) is going to have serious consequences for the sector in Switzerland. This Swiss trade association has just published its biannual survey as part of the 2020 sector study on the Swiss medical technology industry (SMTI).
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ambulatory Surgical Center Association, Dyansys, Neurosurgical Care.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Life Spine, Medhub, Medtronic, Nanovibronix, Radlogics, Rti Surgical.
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
The latest global regulatory news, changes and updates affecting biopharma, including: New TGA service to ease the burden of biowaivers; FDA formalizes outside experts program; FDA unveils Digital Health Center of Excellence; FDA updates clinical trial guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, BMS, Crispr, Emmetrope, Genocea, Knight, Lilly, Medeor, Mustang, Nicox, Ocumension, Redhill, Therapeuticsmd, UCB, Vertex.
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