Center for Drug Evaluation
FDA names Tracy Beth Heg as acting CDER chief
Tracy Beth Heg; acting CDER chief; FDA leadership; Center for Drug Evaluation and Research; COVID-19 vaccine safety; drug regulation; U.S. Food and Drug Administration
Top Drug Regulator Richard Pazdur to Retire from FDA Amid Industry Concerns
Richard Pazdur; FDA; retirement; Center for Drug Evaluation and Research; drug regulation; Marty Makary; leadership turnover
FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny
FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays
‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil
FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority
Innovent Biologics’ Picankibart Achieves Success in Phase III CLEAR-1 Study for Moderate to Severe Plaque Psoriasis
Innovent Biologics, picankibart, Phase III CLEAR-1 study, moderate to severe plaque psoriasis, IL-23p19 class, new drug application, Center for Drug Evaluation, National Medical Product Administration.
FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency
FDA, CDER (Center for Drug Evaluation and Research), C3TI (CDER Center for Clinical Trial Innovation), Clinical trial innovation, Efficiency, Drug development, Trial design, Collaboration