Question 1 Describe all the five scenarios as recommended by Mashelkar's task force for biopharmaceuticals

Question 2 Write in detail about scientific review required in US for the medical devices for which insufficient information exists to assure safety and effectiveness

Question 3 List out the procedures for filing a 510(k) application and a Pre-market approval application for medical devices in the USA

Question 4 What is the significance of ‘immunogenicity' in safety testing of a biosimilar product? What is the scope and purpose of the guidelines pertaining to the quality issues of the biosimilar product?

Question 5 Describe the procedure for import of cosmetics in US and India

Question 6 Enumerate functions of

• CDRH's Office of Device Evaluation (ODE)
• CDRH's Office of Surveillance and Biometrics (OSB)
• CDRH's Office of Compliance (OC)
• CDRH's Office of Health and Industry Programs (OHIP)