Question 1:
Show the procedures for filing a 510(k) application and a Pre-market approval application for medical devices in the USA.
- Show out the procedures for filing a 510(k) application
- Explain about Pre-market approval application for medical devices in the USA
Question 2:
Explain all the five scenarios as recommended by Mashelkar's task force for biopharmaceuticals.
- Recommendations for Biopharmaceuticals from "Mashelkar's Task Force"
- Recommended procedure for regulation of recombinant pharma products derived from Living Modified Organisms (LMOs).
- Describe in brief all the five possible scenarios