Aug 18, 2022 | Drugs, FDA and USDA Regulatory Update
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted...
Aug 15, 2022 | Drugs, Issue of the Month
By Susan Crane, EAS Senior Advisor for OTC Drugs and Labeling As part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations...
Aug 4, 2022 | FDA and USDA Regulatory Update
What You Need to Know EAS food facility registration clients will remember during the 2020 renewal period, the FDA had sent reminders of the requirement per 21 CFR 1.232(a)(2), of a unique facility identifier (UFI) for every location registered with the agency as a...
Jul 28, 2022 | Drug and Device Corner, Drugs, Medical Devices
EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504. The FDA has finalized the UDI draft...
Jul 26, 2022 | FDA and USDA Regulatory Update
What You Need to Know FDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part...
Jul 6, 2022 | Drugs, EASeNews, Extra Article, Medical Devices
EAS Consulting Group is pleased to welcome Lisa El-Shall to the EAS management team. As Senior Director for Drug and Device Services, she will be responsible for advising clients on FDA regulatory and GMP compliance matters related to pharmaceutical and medical device...
