PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Canadian government, Center for Drug Evaluation and Research, EMA, Stop TB Partnership, Therapeutic Goods Administration.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainscope, Optellum, Ortho Clinical Diagnostics, Shape Memory Medical.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIJ seeks feedback on apps for mental health.
If the biopharma industry thought its round-the-clock efforts and considerable financial investments in tackling COVID-19 would earn it good will in the U.S. Congress, those hopes were dashed March 23 when both Democrats and Republicans serving on a Senate Health, Education, Labor and Pensions subcommittee reverted to blaming drug companies for much of what’s wrong with the U.S. health care system.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd.
The latest global regulatory news, changes and updates affecting biopharma, including: End of the road for ‘standing’ case; TGA gives labeling guidance; Trial fraud leads to prison sentences.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Cansino, Incyte, Insmed, JCR, Merck, Protagonist, RDIF, Zealand.
With the December PDUFA date already blown, Pfizer Inc. is headed into a day-and-a-half FDA advisory committee meeting this week to make the case for 2.5-mg tanezumab, a potential first-in-class treatment in the U.S., partnered with Eli Lilly and Co. Inc., for chronic pain due to moderate to severe osteoarthritis.
“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia.
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