Explain the approval process of new drug under 505 (b) (2).
[5 marks]Define new drug according to FDA. Explain in detail the new drug development process with the time course for each phase.
[6 marks]Discuss about various Stages of drug discovery.
[5 marks]Describe general consideration, specific requirements and contents of an NDA.
[5 marks]Discuss about Organization structure and Overview of regulatory authorities of India.
[5 marks]Write a note on Preclinical studies as per CDSCO.
[6 marks]Explain the purpose and procedure for IND application to USFDA.
[5 marks]Describe the procedure for Generic drug approval from CDSCO in India.
[6 marks]Describe Informed Consent process and procedures for clinical trial study.
[5 marks]What is the importance of investigator’s brochure? Give a brief outline of clinical research protocols.
[6 marks]Write a note on International Good Clinical Practices.
[5 marks]What is Common Technical Document? Describe various CTD modules.
[5 marks]What is DMF? Write a note on Type of DMF.
[5 marks]Describe how Waxman-Hatch Act has simplified and facilitated approval of generic products in US?
[6 marks]Briefly explain about Safety monitoring of medical products.
[5 marks]Give the composition, functions and responsibilities of Institutional review board.
[5 marks]Discuss content of ASEAN Common Technical Document. Q. 6 (a) How did Bolar provision give boost to ANDA approval process in USA?
[6 marks]Discuss the salient features of FDA guidelines for clinical trials in India.
[5 marks]Write scope and approaches of 21 CFR part 11.
[6 marks]Write note on Purple book.
[5 marks]