Category: Regulation
Industry
Pharmaceutical
Regulation
The FDA approved drugs of 2022
As the holiday is approaching, the list of approved drugs for this year can be finalized. Of the 32 drugs for 2022, there are 13 large molecules. The biological drugs keep the growing trend. Among these...
Industry
Pharmaceutical
Regulation
A glance at the current status of regulatory guidance for Bioanalysis
As the December of 2022, half year after ICH published the finalized M10 guidance, only EMA announced the adoption of ICH from Jan. 21st, 2023. FDA published notice of the finalized ICH M10. But FDA did...
Industry
Pharmaceutical
Regulation
How ICH Guideline Topics Are Named And Categorized?
If you are new to the regulatory guidance, even some peers in the regulated field for a while, it is still quite unclear what are the M10, S6, R2 means in ICH guidelines. So this article...
Chemical
Pharmaceutical
Regulation
What are Nitrosamine Impurities in Drugs
Nitrosamine, formally known as N-nitrosoamine, is a class of organic molecules with the above core structure. These type of chemicals are believed carcinogenic due to their potential as alylating reagents inside cells, which will cause cancer....
Pharmaceutical
Regulation
A Quick Guide for IND Application
How many types of FDA IND application? There are multiple types of IND application. Generally, your IND will be either 1) commercial or 2) research. It depends on whether it will be used to support marketing application afterwards. There are then three...
Pharmaceutical
Regulation
A Quick Guide to FDA pre IND Meeting
What is a pre IND meeting with FDA? Pre IND meeting with FDA is an important step of IND application. An IND application is (a) sponsor(s) that submit the product’s data and information to FDA (Food...
cGMP
GLP
Industry
Regulation
GLP VS GMP testing
For beginners to regulated pharmaceutical industry, GLP(Good Laboratory Practice) and cGMP(Current Good Manufacturing Practice) probably are the two most encountered regulatory standards. In some case, it may feel like very similar in terms of analytical testing....
Industry
Regulation
FDA-Approved Radiopharmaceuticals
I am very interested in radiopharmaceuticals, so I posted several posts about it. And Recently, I am thinking about summarize the radiopharmaceutical that already approved safe and effective in treat disease. I found http://www.radiopharmaceuticals.info is a...