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Rutgers University Regulatory Affairs Discussion

Rutgers University Regulatory Affairs Discussion

Rutgers University Regulatory Affairs Discussion

Description

question 1

Create your initial post in response to the following:

Give one reason why drugs should or should not be advertised?

Return to the board and read over the posts of your fellow classmates. Choose at least one classmate and create a post responding to his/her initial post on the Discussion Board.

  • question 2

Create your initial post in response to the following:

Provide a pro and a con for the current regulations in place for generics.

Return to the board and read over the posts of your fellow classmates. Choose at least one classmate and create a post responding to his/her initial post on the Discussion Board.

question 3

Create your initial post in response to the following:

Provide a link to an article that discusses regulations on a generic drug or a biosimilar.

question 1 response post

Drugs should be advertised so that the general public can be aware of their options and ask their doctors meaningful questions to get informed. Even though doctors are likely to know whats best for treatment it is good to also be aware to try and be informed and possibly try new and better treatments.

question 2

Pros

  1. Need not to submit drug clinical data on safety and efficacy.
  2. Need not to do drug toxicity on animal’s i.e., preclinical studies.
  3. Hatch- Waxman Act helpful to speed up the approval process for generic drugs.
  4. Generic molecules are bioequivalent to that of branded drug
  5. Available at low cost than branded drugs

Cons:

  1. It will take one and half year to get approval, even though it is thoroughly evaluated.
  2. Poor quality maintenances due to involvement of cheap labor during the manufacturing process.
  3. Confusion of patient regarding appearance and taste of the product compared to branded drug.
  4. Chance of Producing adulterated product by considering the cost and not having stringent monitoring by FDA sometimes.
  5. More competition among manufacturers of generics.

question 3

This is my article:  (Links to an external site.)“>https://www.uspharmacist.com/article/getting-up-to-speed-with-generic-regulations (Links to an external site.)

My article discusses pharmacuetical changes that took place for generic drugs in 2020. It focused on changes made to the approval processes for generics. They included being complient with the BCPI act and FD&C act. The FDA wants to increase affordable health care by increasing the market and making treatment more readily available.

Reply

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