Jun 3, 2021 | Drugs, Webinar
Presented by Joe McGuinness, EAS Independent Consultant. July 13, 2021 at 1pm eastern. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s...
Jun 1, 2021 | Drugs, EAS in Action
EAS pharma expert, Joe McGuinness, published an article in Tablets and Capsules on coming to terms with the requirement of GMP implementation. While GMPs have always been required (in theory) for Active Pharmaceutical Ingredients (APIs), the FDA often found itself at...
May 24, 2021 | Drug and Device Corner, Drugs, Medical Devices
With the Over-The-Counter Monograph User Fee Program (OMUFA) 2021 facility user fee now past due, the FDA would like to remind all drug establishment manufacturers to make payment immediately. Please note the FDA has not issued invoices for this fee. The agency’s only...
Apr 26, 2021 | Drug and Device Corner, Drugs, Medical Devices
After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC...
Apr 26, 2021 | Drugs, Issue of the Month
Amy Scanlin, M.S. In April 2021 FDA issued Final Guidance for Industry concerning Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. In an effort to meet designated timelines,...
Mar 31, 2021 | Client Update, Drugs
After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC...
