Explain about pre-market approval application, Biology

Assignment Help:

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

Related Discussions:- Explain about pre-market approval application

Define requirements of vitamins and minerals during surgery, Define Require...

Define Requirements of Vitamins and Minerals during Surgery? Normal tissue stores of vitamins are required for the metabolism of carbohydrates and protein. Deficiency states li

Define effect of fat on quality and quantity of human milk, Define effect o...

Define effect of Fat on quality and quantity of human milk? Fat content of milk appears to be subject to variability as compared to other constituents. The average fat content

Define points to remember regarding to food processing, Define Points to Re...

Define Points to Remember regarding to Food Processing? 1. Conversion of raw materials and ingredients into acceptable consumer products is referred to food processing, which c

Explain the gomez classification, Explain the Gomez classification? It ...

Explain the Gomez classification? It will be of interest to you to learn that in Mexico, a child specialist named Gomez and his co-workers proposed a classification expressing

Foot-and-mouth disease, Foot-and-mouth disease Foot-and-mouth disease ...

Foot-and-mouth disease Foot-and-mouth disease (FMD) is an extremely contagious viral disease of cloven footed animals most notably cattle, pig and sheep. It is well known for

What is the bone matrix, Q. What is the bone matrix? What are its main comp...

Q. What is the bone matrix? What are its main components? Bone matrix is the content that fills the intercellular space of the osseous tissue the bone matrix is made of mineral

Reduction in the birth rate, State three conditions in a society which coul...

State three conditions in a society which could contribute to a reduction in the birth rate. Birth rate might be decreased by (i) later marriages (as smaller families), (

Agro industrial-post-partum anoestrus, Post-partum anoestrus Reproduct...

Post-partum anoestrus Reproductive efficiency among animals greatly depends upon detection of estrus. This is even more important in reference to small herds managed under tro

Obsessive compulsive disorder (ocd), OBSESSIVE COMPULSIVE DISORDER (OCD): ...

OBSESSIVE COMPULSIVE DISORDER (OCD): OCD is another common neurotic disorder seen in the hospital.  Definition  Obsessive Compulsive Disorder is  the disorder characte

Which term describes first step in production of urine, In studies of human...

In studies of human body, which of the below terms is used to describe the first step in production of urine? Is it: a) Tubular reabsorption b) Tubular secretion c) Glome

Write Your Message!

Captcha
Free Assignment Quote

Assured A++ Grade

Get guaranteed satisfaction & time on delivery in every assignment order you paid with us! We ensure premium quality solution document along with free turntin report!

All rights reserved! Copyrights ©2019-2020 ExpertsMind IT Educational Pvt Ltd