Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, March 23, 2020
Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency
Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
“The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.”
For drugs subject to REMS with laboratory testing or imaging requirements, healthcare providers prescribing and/or dispensing these drugs should consider whether there are ..