The FDA Law Blog

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

Documentation 59

Documentation FDA Communication 59

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.” Several branded medicines are available that feature holograms on the packaging or in the blister pack.”

Packaging 111

Packaging Labelling Documentation Dosage 111

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.

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. What if I do not qualify for the exemption?

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

Viseven

SEPTEMBER 18, 2024

By the end of 2026, the company will be able to analyze two million genomes. Cloud computing facilitates effortless collaboration Cloud computing makes it easier for life sciences companies to communicate and collaborate globally. This innovative approach has brought more than 40 successful drug discovery projects to AstraZeneca.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Vaccines 52

The FDA Law Blog

FEBRUARY 13, 2025

The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. Details of the PCCP will be publicly available (i.e.,

FDA 71

FDA Documentation Labelling Method Validation 71