Environmental Impact Assessments are Required by FDA, NEPA
By Charles Eirkson, EAS Independent Consultant The National Environmental Policy Act (NEPA, 1969), requires that potential environmental impact of actions, e.g., approvals of new drugs, biologics, food additives, be addressed by the U.S. Food and Drug Administration...
Drug and Device Corner April 2022
We are 5 months out from the UDI / GUDID enforcement date of 22 September 2022 for Class I and unclassified devices, are your processes in place? Do you know what requirements are applicable to your operation? Helpful information can be found on FDA’s webpage GUDID...
Good Auditing Practices, Making the Most of Your Internal Review
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
FDA Takes OTC Accelerated Stability Data Very Seriously
Did You Know? FDA Takes OTC Accelerated Stability Data Very Seriously The FDA expects all drug products to bear an expiration date that is backed by scientifically sound data and projections, regardless of whether that drug is an NDA, ANDA or Over the Counter (OTC)...