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...
Apr 9, 2021 | Client Update, Foods
FDA has released an action plan, called Closer to Zero, that aims to reduce exposure to toxic elements in foods intended for babies and young children. This multi-phased approach focuses on levels of arsenic, lead, cadmium and mercury in these foods to the greatest...
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...
Mar 1, 2021 | Cannabis, Client Update
EAS is closely monitoring progress of bi-partisan legislation introduced to the 117th Congress on February 4, 2021, H.R. 841, the Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2021. The bill seeks a federal regulatory framework for hemp...
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...
