Establishing an Effective Environmental Monitoring Program
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Responding to an FDA Form 483 – Tips for Compliance Success
By Amy Scalin, M.S. Hearing from FDA often means one thing: The Agency has found issues with your operations that require a swift response and corrective actions. FDA uses numerous tools to notify firms of regulatory compliance enforcement. Most commonly, a firm will...
New York High Court Rejects Talc/Asbestos Causation Testimony, Reaffirming Need for Scientific Dose Assessment
By William A. Ruskin, EAS Independent Consultant and William L. Anderson, former partner at Crowell & Moring This article is a revision of an article that first appeared in the Lexis Nexis publication Editor’s Note: Mr. Anderson is a former partner with...
Adverse Event Reporting for OTC Drug Products
By Susan Crane, EAS Senior Advisor for OTC Drugs and Labeling As part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations...