The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Broncus Holding Corp.’s thermal vapor treatment system Intervapor has won approval from China’s NMPA. The system is used for the treatment of chronic obstructive pulmonary disease (COPD), lung cancer and other pulmonary diseases.
The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
Even though Congress isn’t likely to approve BsUFA III for several months, the FDA is getting a jump on one of the BsUFA commitments it negotiated with industry to pilot a regulatory science program to facilitate the development of biosimilars and interchangeables.
A total of seven new molecular entities (NME) have been approved by the U.S. FDA this year, while another seven therapies received dreaded complete response letters from the agency. Out of 9 FDA approvals in February, including two BLAs, three NDAs, three supplemental applications, and one abbreviated NDA, were three NME clearances.
PERTH, Australia – Australia should be at the front of the line among developed nations when it comes to innovative drugs and devices, but health policies must evolve to respond to changes in technology and global trends, Johnson & Johnson (J&J) said. Although Australia’s health policy has served the country well, tensions in the system are becoming seismic shifts that mirror international trends, J&J said in a recent report on Australia’s health system.
In what is undeniably one of the busiest years for governmental agencies across the globe, 2021 churned out a 12% increase in regulatory news over the previous record year of 2020.
