European Pharmaceutical Review

NOVEMBER 24, 2022

With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

Packaging 111

Packaging Labelling Documentation Dosage 111

The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA 59

FDA Labelling Packaging Documentation 59

The FDA Law Blog

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. report certain device malfunctions, and.

Labelling 64

Labelling FDA Communication Documentation 64

DiversifyRx

JULY 11, 2024

The exemption will last until November 27, 2026, for those small dispensers who qualify. To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request.

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

FDA 71

FDA Documentation Labelling Method Validation 71