When did a product get 505(b)(2) NDA certification?

Posted by A Smith on June 13th, 2021

NDA certification is a certification procedure that helps to get certification and approval from the NDA. While working as a pharmaceutical company and while willing to launch a new product to the market, the certification is a proper thing that is needed to be considered to gain the certification. Here are the factors that will analyze the time when a product can get 505(b)(2) NDA certification from the end of the certification or when you should have to apply for the 505(b)(2) NDA certification.

1. Conversion of power

When the pharmaceutical company wants to decrease or increase the power of the particular medicine, the company should have to take permission from the end of the NDA so that the changes in the power of the treatment can be increased or decreased. This is denoted as a primary reason for which a person should choose the 505(b)(2) NDA certification or approval.

2. Change of formulation

When a pharmaceutical company wants to make severe or minute changes in the formulation, at that time, they also need certification from the end of the 505(b)(2) NDA; This is also going to be a practical step for the NDA to know that the product is not harmful to the user and the formulation is also going to be an accurate one for you in most of the cases. So, while changing the medicine formulation, it is also needed for the pharmaceutical company to ensure that they have certification and have proper license to gather effective results from the end of the company.

3. A bioequivalent product

When a pharmaceutical company launches or changes the medicine to a bio-equivalent product, they can take help from the 505(b)(2) NDA certification. This is also denoted as a fundamental reason for which a company should apply for the certification. This is ao going to be a reason for which the certificate will be gathered here.


These are the foremost reasons why pharmaceutical companies should apply for the 505(b)(2) NDA. This is also going to be a guideline for the pharmaceutical company for which they can apply for the certification. This is also going to be the foremost reason for which a company can use for the certification procedure that is very important for the accreditation of a medicine. Besides that, this is also going to be a procedure that helps in the certification and detection of proper medicine also.

A Smith

About the Author

A Smith
Joined: August 22nd, 2017
Articles Posted: 49

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