The FDA Law Blog
DECEMBER 8, 2022
Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. All packaged foods served or sold on transportation carriers (e.g., After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate.
European Pharmaceutical Review
JULY 5, 2023
The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.
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The FDA Law Blog
OCTOBER 5, 2022
In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.
The FDA Law Blog
FEBRUARY 21, 2024
Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3,
The FDA Law Blog
NOVEMBER 2, 2023
CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”
European Pharmaceutical Review
NOVEMBER 14, 2023
In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.
Board Vitals - Pharmacist
NOVEMBER 8, 2022
Bench to bedside: In its definition, the National Institute of Health characterizes EBM as “the intersection of research, evidence and clinical practice.” Step 1: Problem definition Remember how Dr. Evans and his care team observed a persistent incidence of secondary issues among patients admitted with fractured hips?
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