OctariusRx

MAY 13, 2024

Our 2024 nursing calculations quiz is now available. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patient’s weight in kilograms. Read the medication label carefully: This is a critically important step and one that often leads to errors and potential patient harm.

Long-Term Care Facilities 68

Long-Term Care Facilities Labelling Medication Labelling Documentation 68

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. Loose Ends IDEs.

FDA 105

FDA Documentation Labelling Communication 105

pharmaphorum

MARCH 8, 2022

The company didn’t conduct a conference call to discuss the findings, but took the unusual step of publishing a frequency asked questions (FAQ) document on the study, headlined with a non-committal statement about whether the data were “clinically meaningful.”

Chemotherapy 52

Chemotherapy Documentation Labelling 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 FDA Law Blog

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

Dosage 45

Dosage Documentation Labelling 45

The FDA Law Blog

FEBRUARY 28, 2024

FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024. The next document in the docket is a letter from Dr. Marks referring to an upcoming October 2, 2023, joint (virtual) meeting with CDER and Oncopeptides. Tobolowsky & Michelle L. On August 4, 2023, Oncopeptides submitted its appeal.

FDA 59

FDA Documentation Labelling 59