Apr 22, 2022 | Issue of the Month, Medical Devices
By Susan Crane, EAS Independent Consultant It’s now been 5 years since FDA updated the regulations for establishment registrations and drug listings. Despite numerous on-line reference materials and tutorials available, it appears that some companies still have...
Apr 21, 2022 | Did You Know, Drugs, Foods, Tobacco, Veterinary
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...
Apr 19, 2022 | Drug and Device Corner, Drugs, Medical Devices
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...
Mar 30, 2022 | Foods, Issue of the Month
By Jayne Roth, M.P.H, REHS, EAS Independent Consultant At the end of 2021, a survey fielded by the National Restaurant Association, showed that 78% of operators said their restaurant did not have enough employees to support customer demand. Understaffing is not only...
Mar 24, 2022 | Did You Know, Drugs
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)...
Mar 21, 2022 | Drug and Device Corner, Drugs, Medical Devices
FDA announced the fiscal year 2022 OTC-Monograph Drug User Fee rates in the Federal Register Vol 87, No 51 published today 16 March 2022. These fees cover FDA’s FY2022 which runs from October 2021 through September 2022. The facility fees for FY 2022 are due on 1 June...
