The guidelines include information on who must report an AER, which events must be reported, how to submit an AER, and how long AER records must be kept.
FDA has created a new, concise “At-a-Glance” outline on adverse-event reporting (AER) for dietary supplements. The guidelines include information on who must report an AER, which events must be reported, how to submit an AER, and how long AER records must be kept.
Manufacturers, packers, and distributors are responsible for submitting AERs no later than 15 business days after receiving notice of an AER.
Nutritional Outlook thanks Harry Rice, PhD, for the tip.
The Nutritional Outlook Podcast Episode 33: Keeping up with contract manufacturing
July 26th 2024Nutritional Outlook talks to Lauren Samot, commercial innovation leader, and Blayney McEneaney, sales executive at Vitaquest International, about trends within the contract manufacturing space, and the ways in which contract manufacturers like Vitaquest keep up with the market and differentiate themselves from the competition.