FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?
By EsqSocial Corporation 10/04/21
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s) handling of a whistleblower case that alleged improprieties surrounding compliance inspections of vaccine manufacturing facilities. Special Counsel Kerner’s letter to the President coincided with his closing of the investigation and his conclusion that the agency’s actions met...
By: Mintz - Health Care Viewpoints