Jun 16, 2021 | Client Update, Drugs
As you are probably aware, per 21 CFR 207.57 FDA drug establishment registrants must review and, if necessary, update listing information each June and December. This includes all drug listings, including bulk products. EAS provides support with facility registrations...
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...
Jun 1, 2021 | Extra Article, Uncategorized
and are excited to provide onsite services again! Many EAS consultants are fully vaccinated and are back to traveling to client sites providing that in-person and focused support that sets EAS apart. When you are ready to schedule your next in-person consulting –...
Jun 1, 2021 | Foods, Issue of the Month
By Charles Breen, EAS Independent Advisor for Food Safety The popularity of new breweries, wineries and craft distilleries has created a community of devoted followers. Many producers do not realize one crucial thing—in addition to the Treasury Department’s Alcohol...
Jun 1, 2021 | Did You Know, Tobacco
FDA recently announced a plan to propose product standards banning menthol as a flavor in cigarettes and banning all characterizing flavors (including menthol) in cigars within the next year. If implemented, this ban will apply to all manufacturers, distributors,...
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...
