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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3 Subpart B reserves §§ 820.20 – 820.30, 820.40.

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November 2023 Newsletter

Safe Biologics

The difference between the definitions of interchangeability in Europe and in the U.S. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber.

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Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

So much smaller, much leaner and definitely more startup mentality. And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. So there’s still definitely a lot of PharmD in there.

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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law Blog: Biosimilars

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

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What is a natural health product? Health Canada’s findings upheld by Federal Courts

Pharma in Brief

The statutory definition In Canada, natural health products are defined as drugs under the Food and Drugs Act but are generally not subject to the Food and Drug Regulations. These distinctions are important as they determine the regulatory burden required to market a product in Canada. In its August 16, 2023 decision in Le-Vel Brands, LLC v.

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Over-the-Counter Choices Pharmacist Role and Resources

FADIC

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.