Jan 7, 2021 | Dietary Supplements, Foods, Issue of the Month
By Gisela Leon, EAS Independent Consultant and Instructor for Food and Dietary Supplement Labeling Seminar In times of COVID-19, many people are restricted to staying at home, working from home, and cooking at home more than ever before. Cooking at home requires the...
Jan 6, 2021 | Client Update
The FDA published today in the Federal Register Vol. 86, No. 3 a withdrawal of their December 29, 2020 Federal Register Notice entitled Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021./p> With the FDA’s most recent announcement,...
Jan 4, 2021 | Client Update, Drugs
Last week FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice. Under the new 2021 rates: Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $14,060. Owners of a contract...
Jan 1, 2021 | Did You Know
In the competitive FDA space, mergers and acquisitions of brands and formulations are a common occurrence and help gain a competitive edge. These critical decisions have far reaching implications, including exposure to regulatory risks which can have devastating...
Jan 1, 2021 | EASeNews, Extra Article
From our family to yours, EAS Consulting Group wishes everyone a healthy and happy New Year! 2020 will certainly be remembered as one of immense challenges and creative opportunities. From the push to develop effective testing and vaccines, to supply chain issues that...
Jan 1, 2021 | Drugs, Foods, Issue of the Month
Robert Fish, Independent Advisor, Quality and Compliance Every year FDA monitors thousands of recalls of regulated products (over 7,000/year). Though most product recalls are voluntary, the FDA can also order them. Recalls can be very damaging to the reputation of a...
