The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve.
As Prescribed
YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and transfers of value made to healthcare providers. On August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published a Proposed Rule seeking to expand the Open Payments program, including the number and types of covered recipients and payment categories.