Chuyên mục: Regulatory affair

The Federal Trade Commission warns drugmakers against improper patent filings

The Federal Trade Commission (FTC) is warning drug companies against improper patent filings, saying that

Circular No. 16/2023/TT-BYT about marketing authorization registration of contract manufactured medicine, medicine of technology transfer in Vietnam

This circular prescribes marketing authorization registration of contract manufactured medicine, medicine of technology transfer in

MHRA warns of new serious side effects of Dupixent®

On November 29, 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced new serious

A FDA-approved product

Not all products go through FDA experts’ evaluation before they are offered for sale. In

A patient instruction for use (IFU) document for human prescription drug and biological products by FDA

In July 2022, the FDA published guideline providing recommendations for developing the content and format

The top 10 highlights in Circular no. 08/2022/TT-BYT on Marketing Authorization of drugs and medicinal ingredients

On September 5th 2022, Mr. Do Xuan Tuyen, Deputy Minister of Health, promulgated the new