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By - SebastianFeye

CBD – To Be or Not to Be a Drug? Predicting the Impending FDA Regulations on Cannabis.

This blog post was written following a ReedTech webinar (dated 11.7.2019) which focused on helping companies understand how to navigate the state of Cannabidiol (CBD) regulatory environment. This post is for informative purposes only and to provide guidance to minimize risks when labeling, promoting and selling cannabis-derived products in the US. To date, FDA has approved only one CBD drug

By - SebastianFeye

Part 11 compliance is critical, Firms need to be aware of compliance with using the Cloud

21 CFR Part 11 – Electronic Records Part 11 of the Code of Federal Regulations applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions in regards to electronic record keeping. [1] It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software

By - SebastianFeye

Enterprise Risk Strategy and Emerging Technologies to address critical needs

On July 31, 2019 I had the opportunity to listen into a PricewaterhouseCoopers (PwC) webinar hosted by SDRAN discussing how to build a risk strategy utilizing emerging technologies such as Artificial Intelligence, Blockchain and IOT to improve quality, strengthen compliance and controls such as adverse event controls, reporting and reduce non-conformances. As technology has advanced, the amount of data being

By - Glen Feye

FDA Issues New Import Data Requirements

One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015. To help meet that challenge in a way that benefits both government and the

By - Glen Feye

Compliance Dates for UDI Regulatory Requirements

Key compliance dates in the UDI final rule. Compliance Date Requirement September 24, 2014 All Class III devicesThe labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices

By - Glen Feye

Strategic and Effective FDA Pre-Submissions

The purpose of the FDA Pre-Submission Program* (formerly Pre-IDE) and Meeting with FDA  is to provide a mechanism for applicants through which they can request feedback from the Food and Drug Administration (FDA) regarding potential or planned 1) Medical device Investigational Device Exemption (IDE) applications, 2)  Premarket Approval (PMA) applications, 3) Humanitarian Device Exemption (HDE) applications, 4) De novo Petitions

By - Glen Feye

Addressing FDA Import Alert and “Notice of FDA Action”

IN LIMBO ON THE BORDER – by Glen Feye FDA is the main gatekeepers for foreign Medical Devices and Drugs imported into the United States. If your shipment is questioned by FDA and receive a “Notice of FDA Action” contact your US Agent and you may need a FDA Compliance Consultant . If your shipment is non compliant- expect