2004D-0283 - Draft Guidance for Industry: Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability
FDA Comment Number : EC3
Submitter : Mr. Narayan Kumar Sowri Date & Time: 10/12/2004 04:10:08
Organization : Alembic
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
S.Narayan Kumar
Regulatory Affairs Manager- Alembic
Alembic Road.
Vadodara-390003 .India.
sowrinarayan@alembic.co.in

To
US Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Ref.: [Docket No. 2004D-0283]

Ref: Draft Guidance for Industry Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.

Dear Sir/Madam:

I am pleased to provide these comments on the Draft Guidance for Industry on Waivers of in Vivo Demonstration of Bioequivalence.

The waivers of in Vivo demonstration of bioequivalence are useful for facilitating registration of new animal drug application. This guidance will reduce the regulatory burden on registration of new animal drug application and reduce the burden of FDA?s reviewing authority. I believe this guidance is more useful tool for the industry and the FDA.

Comments:

1. Comparison to the pioneer product?s formulation is not required; it sufficient to prove the API quality is same as to pioneer.

This guideline will give perfect guidance to bioequivalence waiver. The quality of API is controlled by this guideline.

Suggestion: This draft guideline shall explain the requirement of API.

2. Comparison to the pioneer product?s formulation is not required, it sufficient to prove the other ingredients are not to cause pharmacologic effects.


The quality of exepients is controlled by this guideline.

Regards
Narayan Kumar


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