The Modernization of Cosmetics Regulation Act of 2022 (commonly known by its acronym “MoCRA”) was signed into law on December 23, 2022. Its intent is to modernize federal regulatory oversight of cosmetic and personal care products and create a comprehensive and uniform national framework for their regulation. Contained within MoCRA
Why Are Cosmetic Claims Substantiation Studies Important? When approaching a claims-support study for any product that produces a cosmetic endpoint, it is important to understand the types of claims available. Puffery, or emotive claims, are meant to grab the emotions of consumers but don’t necessarily say much about product benefits.
Planning a successful clinical study begins with some central questions: What question(s) do we want to answer? What statistical methods will help us answer these questions? What data do we need to collect? How will we collect it? From whom and from how many?
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021. One might argue that chemical contaminants have always been present in
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021. One might argue that chemical contaminants have always been present in
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant Types of Contaminants that are Found in Drug Products Classification of Drug Product Chemical Contaminants and their Sources API Impurities Extractables And Leachables Supply Chain
The term Environmental Monitoring generally refers to the processes and activities that are conducted for the purpose of characterizing and monitoring the quality of a defined environment, with the eventual goal of controlling the quality of that environment. Environmental conditions that are often monitored include but are not limited to
What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch of the science that investigates those effects using laboratory animals upon which testing is conducted. In contrast, in vitro toxicology is the branch of the
Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.” With only a few exceptions, OTC Drugs may be launched in
Testing for product safety and claim support is crucial in the highly competitive, possibly soon-to-be-regulated personal care market. If you are just getting started, or need a refresher course, seek guidance from experts. These days, finding information is simple. Search Google for “cosmetic claim support” and find 2 million entries
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The Modernization of Cosmetics Regulation Act of 2022 (commonly known by its acronym “MoCRA”) was signed into law on December 23, 2022. Its intent is
Why Are Cosmetic Claims Substantiation Studies Important? When approaching a claims-support study for any product that produces a cosmetic endpoint, it is important to understand
Planning a successful clinical study begins with some central questions: What question(s) do we want to answer? What statistical methods will help us
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant
The term Environmental Monitoring generally refers to the processes and activities that are conducted for the purpose of characterizing and monitoring the quality of a
What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch
Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and
Testing for product safety and claim support is crucial in the highly competitive, possibly soon-to-be-regulated personal care market. If you are just getting started, or
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