Explain about pre-market approval application, Biology

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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

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