The onset of the COVID-19 pandemic and the Jan. 31, 2020, public health emergency declaration that followed pushed those of us working in the life sciences and health care industries into uncertain waters.
Drug sample delivery, pharmaceutical industry educational programs, routine and COVID-19 related patient care visits, rollout of timely diagnostic and surveillance testing and personal protective equipment, and ongoing data collection in open or new clinical trials are just a sample of the issues that had to be addressed.
Business and patient care exigencies soon outpaced the capacity of state and federal regulators to react — the regulators themselves facing staffing shortages, difficult and unprecedented questions, and technological challenges.
Centers for Medicare and Medicaid Services policy statements, U.S. Food and Drug Administration draft guidances and town hall pronouncements, governors' emergency declarations and waivers, and trade and professional society self-regulatory guidance were issued and updated frequently.
Often, these regulatory changes were announced in podium policy or communicated in technical advisory meetings or private correspondence prior to being announced in formal guidance documents. The result was a patchwork of temporary policy pronouncements that bypassed traditional notice and comment procedures.
In this fast-changing ad hoc environment, the vast majority of health care and life sciences companies sought to serve the public health and...
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