European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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FDA Documentation Method Validation Packaging 98

The FDA Law Blog

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.

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Documentation FDA Packaging 57

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. Preparations to support the implementation of the EU AI Act will start in 2024. AI-supported spectroscopy delivers superior pharmaceutical packaging QC The post European regulators prepare for AI in pharma appeared first on European Pharmaceutical Review.

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Packaging Documentation 105

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Not All Pharmacies Can Exempt from The 11/27/2024 DSCSA Requirements. The original article can be found HERE. The DSCSA Adventure continues. The DSCSA Adventure continues.

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Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.

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FDA Labelling Packaging Documentation 57

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. This tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

The Checkup by Singlecare

APRIL 5, 2024

Samples often come in a package of four 2.5 Per Bonza, that paperwork might include a documented Type 2 diabetes diagnosis, medical test confirmation, and evidence of persistently elevated A1C despite oral therapy. mg single-use pens, a one-month supply.

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Insurance Compounding Pharmacies Compounding Insurance Coverage 59