The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biohaven, Direct, Enlivex, Harmony, Moderna, Orca, Redhill, Scynexis, Sorrento, Taysha Gene, Tevogen, Y-mabs.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cefaly Technology, Crossbay Medical, Fh Ortho, Immersivetouch, Micro Medical Solutions, Sonivie.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axovant, CTI, Inventiva, Nanobiotix, Nuvation, Pluristem, PMV, Prestige, Voyager.
The U.S. FDA has several years of experience with computational modeling (CM) for medical device design and testing; however, the movement toward a policy has wanted for a solid body of data on which to base a guidance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
RSS
