2024 Documentation Labelling 
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.
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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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.
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.
The Checkup by Singlecare
AUGUST 3, 2024
It’s also sometimes prescribed off-label to treat major depressive disorder and other mental health conditions. This is why “ensuring patients have the proper documentation is crucial,” says Sazan Sylejmani, Pharm.D. However, some plans may also cover off-label uses as long as a drug is medically necessary in those situations.
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FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024.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.
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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