May 1, 2020 | Did You Know, Drugs
Did you know there are exemptions/waivers for FDA’s eCTD requirements for CDER applications? In February 2020, the FDA released a Guidance Document regarding eCTD requirements for regulatory submissions. This guidance document describes how content must be organized...
Mar 1, 2020 | Did You Know, Foods
Preventive Controls for Animal Food/Feed is a requirement for all manufacturers of animal food/feeds. EAS expert, Jerry Poley, who assists clients with food safety audits including requirements for HACCP, FAMI QS, FPA Safe, PAACO (Professional Animal Auditor...
Feb 1, 2020 | Did You Know, EASeNews
Data Universal Number Systems, commonly known as DUNS are unique, site specific, nine-digit identification numbers provided by Dun & Bradstreet (D&B) and used globally. Free to obtain, FDA and other federal agencies use DUNS numbers to track and verify company...
Dec 1, 2019 | Did You Know, EASeNews, Foods
As innovative food companies develop an array of products to satisfy a discerning consumer, the question of whether food additives intended for use in those products are safe for their intended uses. According to FDA, “GRAS” is an acronym for the...
Oct 17, 2019 | Did You Know, EASeNews, Medical Devices
Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a...
Oct 1, 2019 | Did You Know, Drugs, EASeNews
Did you know that the current regulations for labeling of Over-the-Counter (OTC) drug products were initiated in 1972 as part of the OTC Drug Review? That’s over 50 years ago and the monograph system that arose from that process has not yet come to completion in terms...
