Question 1:
Explain how drug approval is obtained through various Regulatory Bodies in India using a flow diagram?
- List out the different regulatory bodies in India
- List of Guidelines
- Flow chart
Question 2:
Write a note on the following:
a) Hale Amendment
b) Low-Acid Canned Food Regulation
A Hale Amendment
Canner's Amendment
Question 3:
What are the responsibilities of CBER? How vaccines and blood products are regulated by CBER?
- Expand CBER
- Different responsibilities of CBER.
- Explain briefly the importance of CBER in regulation of vaccines and blood products.