Regulation

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...

Whether human research can be conducted without IND

It is a a simple question, but people usually forget to ask when they enter the pharmaceutical industry. Yes, human research can be conducted without an IND(investigational new drug) in certain cases. The FDA has a...

Chemical Industry Regulation

What permits are needed to start a Chemical research laboratory?

The permits you need to start a chemical research lab will vary depending on the size and type of lab, as well as the local regulations. However, some common permits that may be required include: Building...

Pharmaceutical Regulation

One Minute to Learn the Gist of Investigational New Drug (IND) Application

This is a brief note of the IND application intended for peers who just started learning the IND with very little understanding. Please refer to FDA website for more detail, but it will take some time....