Category: Regulation
Chemical
Industry
Pharmaceutical
Regulation
The Ames Test: Unraveling Mutagenic Potential
The Ames test, a cornerstone of genetic toxicology, serves as a crucial tool for identifying potential mutagens and carcinogens. Several regulatory guidelines govern the conduct and interpretation of Ames tests, including OECD Test Guideline 471: This guideline provides...
Pharmaceutical
Regulation
Sci&Tech
ADME Testing: Your Drug’s Journey
Intro Why ADME? In Vitro vs. In Vivo ADME: The Breakdown For a deep dive into the details, you can continue reading for the next 3 minutes. The journey of a drug from the lab to the pharmacy...
Pharmaceutical
Regulation
Sci&Tech
Implement New Approach Methodologies (NAMs) in Drug Development
The landscape of drug development is evolving, with a growing emphasis on reducing and replacing animal testing. New Approach Methodologies (NAMs) are at the forefront of this shift, offering innovative, non-animal methods to assess drug safety...
Pharmaceutical
Regulation
What are drugs made in the US
There’s no strict legal definition of “Made in USA” for drugs enforced by the FDA. However, we can still refer to some regulation requirements to help understand how they are generally categorized in relation to their origin: 1....
Biotech
GLP
Industry
Pharmaceutical
Regulation
Understanding about the FDA’s Embrace of New Approach Methodologies
In a landmark decision signaling a paradigm shift in pharmaceutical safety assessment, the U.S. Food and Drug Administration (FDA) announced on April 10, 2025, a plan to phase out the requirement for animal testing in the...
GLP
Pharmaceutical
Regulation
What non-clinical safety test are used to support drug indicated for pregnant women?
Due to ethical concerns, testing medications directly on pregnant women is strictly limited. Therefore, non-clinical safety tests play a crucial role in assessing potential risks associated with a drug for pregnant women and the developing fetus. Some...
Industry
Pharmaceutical
PopSci
Regulation
New FDA Regulations for Medication Use During Pregnancy and Lactation
Pregnancy is a special period in a woman’s life. Most medications taken by pregnant women can cross the placenta and enter the fetal body, thereby affecting fetal development. The effects of medication vary depending on the...
cGMP
GLP
Regulation
The differences between GLP and GMP in one table
Both GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) are sets of regulations designed to ensure quality and safety, but they apply to different stages of a product’s life cycle。 Here’s an analogy to understand the...
Pharmaceutical
Regulation
Comparison of FDA drug approval pathways in one table
The FDA (Food and Drug Administration) has several pathways for approving new drugs. Each track offers advantages and disadvantages depending on the urgency and data available for the medication. Here’s a breakdown of the four main...
Industry
Pharmaceutical
Regulation
Fluorine in the Spotlight – Review of the FDA’s 2023 New Drug
The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new molecular entities (NMEs) and new therapeutic biological products in 2023, including 33 small molecule drugs. Of these 33 small molecule drugs, 11 contain at...