Regulation

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...

GLP Pharmaceutical Regulation

How to conduct photosafety evaluation of Drugs

Abstract: With the increasing diversity of drug forms, the number of drugs involved in photosafety evaluation has also increased, and the frequency of photosafety being mentioned and discussed has also increased. In fact, many drugs can...

GLP Regulation

The synopsis of GLP

Suddenly, a though occurs in my head how to explain Good Laboratory Practice (GLP) to a beginner. Many people only need to know the key points of GLP. They do not have interests or are not...