CAJICA, Colombia –The government of Costa Rica issued guidelines recently that will allow the country’s social security system to source the country's hospitals with ventilators produced by the faculties of the universities of the Latin American country, during the COVID-19 outbreak.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosense Webster, Setpoint Medical.
Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.
Exploring new regulatory territory, Iovance Biotherapeutics Inc. hit a snag that will delay the submission of the BLA for its tumor-infiltrating lymphocyte (TIL) therapy, lifileucel (LN-144), in metastatic melanoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aegle, Amag, Amphastar, Biogen, Biontech, Curtana, Glycomimetics, Huya, Iovance, Oncternal, Oragenics, Pfizer, Samsung, Y-mabs.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA’s PRV fees drop again; PMDA offering early COVID-19 vaccine advice; NICE, SIGN go long on COVID-19.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Testing labs captured in enforcement action; Ethicon wins injunction against AIM over sutures; TGA updates class I ARTG listing requirements.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Chembio, Haemonetics, Histosonics, Pixcell Medical, Quidel.
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA is proposing its withdrawal from the U.S. market because the required postmarketing study didn’t show clinical benefit.
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