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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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ISO publishes standard on bacterial endotoxin testing

European Pharmaceutical Review

The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). The document contains requirements and guidance for testing for bacterial endotoxins.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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Our 2023 Nursing Calculations Quiz

OctariusRx

Our 2023 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 a critically important step and one that often leads to errors and potential patient harm.

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Timeline Section 524B became effective on March 29, 2023.

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What is Special about September 24, 2023 for the UDI System?

The FDA Law Blog

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.