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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