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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.

Some areas that companies should consider include the following:

  • Supply chain disruption, including active pharmaceutical ingredient (API) and excipient shortages
  • Drug shortages and related FDA notices
  • FDA inspection priority shifts
  • Potential impacts on import surveillance
  • Delays in FDA’s review of pending drug applications
  • Possible impacts on clinical trials and necessary changes to relevant trial documents
  • The impact on drug promotion and new risks created by the changing landscape

For further analysis, please see our March 13 LawFlash, Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries.

A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law. The result of an ambitious effort by lawmakers to overhaul how Florida regulates healthcare, the bills represent a striking departure from the current regulatory environment. Passed during the last week of the legislative session with a July 1, 2019, general effective date, providers will want to begin reviewing their policies in anticipation of the coming change.