Nov 19, 2021 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that we are entering the last month of the registration renewal period for medical device facilities and drug establishments, as well as drug listing certifications. The FDA has provided an Electronic Drug Registration and Listing Instructions website...
Nov 17, 2021 | Client Update, Dietary Supplements
Amazon recently announced flexibility for selling partners to demonstrate of Good Manufacturing Practices (GMPs) for dietary supplements. The new policy requires submission of three demonstrations of quality, two of which are mandatory. The third requirement provides...
Oct 28, 2021 | Dietary Supplements, Foods, Issue of the Month
By EAS Independent Consultant, David Cockram, PhD Nearly every athlete wants something extra that will provide them with an edge over the competition. Optimizing nutrition is certainly a huge part of improving athletic performance. A well-balanced diet, with...
Oct 27, 2021 | Drug and Device Corner, Drugs, Medical Devices
REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period. The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based...
Oct 12, 2021 | Client Update, Drugs
New Initiatives by FDA FDA has proposed revisions and updates to OTC-drug sunscreen requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions. This effort aims to...
Oct 12, 2021 | Client Update, Tobacco
U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial...
