Category: Regulation
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...