Registration of an innovative biological product in US

Registration of an innovative biological product in US

Contents
Classification of the new drug.........................................................................................................3
Functions and activities of FDA......................................................................................................3
Registration process.........................................................................................................................3
Clinical trials....................................................................................................................................5
Phase 1.........................................................................................................................................5
Phase 2.........................................................................................................................................6
Phase 3.........................................................................................................................................6
Current good manufacturing practices (cGMP)..............................................................................6
Time-period.....................................................................................................................................7
For generic medical product............................................................................................................7
Reference.........................................................................................................................................8

Classification of the new drug
The application for an innovative biological product comes under New Drug Application. There
are two types of NDA and these are 505(b)(1) and 505(b)(2) (FDA, 2019b). The 505(b)(1) is
used for approval of a new product whose active ingredients have not been approved previously.
505(b)(2) pathway on the other hand is used for products that contain similar active ingredients
as a previously approved product (The Weinberg Group, 2019). The following pages examine
the process of registering an innovative biological product in the United States considering the
505(b)(1) submission type under NDA in form Form FDA-356h (FDA. 2019a).
Functions and activities of FDA
The FDA or the Food and Drug Administration have the responsibility of protecting public
health. FDA thus ensures that medical devices, drugs, biological products, cosmetics, radiation
emitting products and food supply are secured, safe and efficient (FDA, 2019). It also has the
responsibility to advance public health through speeding up of innovations that increases the
effectiveness, safety and affordability of medical products. FDA ensures that the public have
access to accurate, science based information about the foods and drugs so that they can maintain
and improve their heath.
Registration process
The development of a new drug starts with discovery. After new components have been
discovered prototypes are made. Before the newly developed drug can be tested on humans or in
other words can be passed through clinical trials, it has to shown to be safe and effective. This is
done through pre-clinical trials which are conducted on animals (Woodcock and Woosley,
2008). The IRB or the Institutional Review Board present in private clinical research centers,
hospitals, etc. gives the approval for both the pre-clinical and clinical trials. During these pre-
clinical trials the boundaries for the safe use of the treatment is established before the drug can
be tested on humans during clinical trials. After the pre-clinical trials are conducted on animals
in accordance with the Good Laboratory Practices (GLPs), the results of the same are
documented in technical reports or scientific publications (Aziz, 2017). These documents from
part of a report that has to be submitted before approval for commencing with clinical trials can
be availed.