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Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.

Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections

From personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.

Applying Modern Technology to Pharmaceutical Production Facilities

Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods.

Companies are adopting robotics and biometrics initiatives in drug product manufacturing and modern, robust aseptic processing technologies that afford tangible safety benefits to sterile products.

Applying Modern Technology to Pharmaceutical Production Facilities

Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods.

Jeffrey Barach, Contributing Editor

Tech Companies to Help FDA With Track-and-Trace Solutions

A traceability system to match FDA’s New Era of Smarter Food Safety Blueprint is a must for food manufacturers. But traceability goals will require more than regulations; a partnership between technology providers and food manufacturers will be essential.

Margaret Knight’s flat-bottomed bag machine patent model. Courtesy of the Smithsonian, National Museum of American History.

PACK to the Future: The Story Behind the Historical Exhibit at PACK EXPO Las Vegas

Take a journey through the history of packaging, explore milestones that shaped the present, and learn more about industry trends influencing the future.

Devices Getty Images 624567292 Sep Oct 2018

FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)

The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

Expedite Med Device Approval with FDA’s New Program

Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.

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How FDA Food Supply Data Supports COVID-19 Vaccine Distribution

In the latest FDA Voices post, Dr. Stephen Hahn and Frank Yiannas, M.P.H. discuss how the new data analysis tool, 21 FORWARD, is helping food and agriculture workers receive vaccines.