Regulatory One: New Drug Application (NDA)

What is a New Drug Application (NDA)?

 

The NDA is the vehicle through which drug sponsors (pharma companies) formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

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In simple terms “It is an application filed with USFDA to get approval for marketing a new pharmaceutical for sale in the U.S.”

Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization.

I. Goals of NDA-

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

• Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

• Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

• Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

II. Chemical type and review classification codes for NDA-

Chemical type classification

 

Number	Meaning
1	New molecular entity (NME)
2	New ester, new salt, or other noncovalent derivative
3	New formulation
4	New combination
5	New manufacturer
6	New indication
7	Drug already marketed, but without an approved NDA
8	OTC (over-the-counter) switch

Review Classification

 

Letter	Meaning
P	Priority review drug: A drug that appears to represent an advance over available therapy
S	Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug
O	Orphan drug - a product that treats a rare disease affecting fewer than 200,000 Americans

 III. Facility and Drug Registration for filing an NDA-

 

 Within 5 days of filing the NDA-

•  The facility should be registered with FDA using form FDA 2656(Registration of Drug Establishment/Labeler Code Assignment form).

• The product(s)/Drugs to be listed with FDA using form FDA 2657 (Drug listing form) .

Note : From June 1, 2009 FDA is accepting only electronic submissions of forms FDA 2656 and 2657.

 

To find more information please click here:  Regulatory One: New Drug Application (NDA)