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
Tuesday, June 23, 2020
FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic
One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections. The public counts on the FDA to review and, when appropriate, to approve or clear medical products that are so important to patients and health care providers.
I am pleased to announce today that the FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years. For instance, we are currently on target to meet our user fee goals for drugs this year by reviewing and taking timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic.