OR WAIT null SECS
© 2022 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2022 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
June 22, 2022
Agency leaders seek to build public trust in science and gain support for regulation.
June 17, 2022
Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.
May 24, 2022
ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.
May 16, 2022
Plan to keep new methods adopted during COVID in place.
May 04, 2022
Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.
April 20, 2022
Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.
April 18, 2022
Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.
April 13, 2022
Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.
April 12, 2022
Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.
April 07, 2022
Several legislative initiatives on table that would extend agency’s reach