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.

Packaging 92

Packaging Documentation 92

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

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., Potassium was maintained within low normal range (3.8-4.0

Packaging 52

Packaging Documentation 52

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.

FDA 89

FDA Documentation Method Validation Packaging 89

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.

FDA 59

FDA Labelling Packaging Documentation 59

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.

Insurance 59

Insurance Compounding Pharmacies Compounding Insurance Coverage 59

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. Eric Halioua: We forecast to get the final report of the current clinical trial (P-I/II PDC-LUNG-101 trial) in Q2 2024. Smriti: Please share the development timeline for the PDC*lung01, when can we expect the next phase of development?

Immunization 40

Immunization Vaccines Health and Personal Care Stores Labelling 40