How to Obtain U.S. FDA Approval of Herbal Based Drugs. November 20, 2012

November 19th, 2012 | Categories: 2012 | Tags:

How to Obtain U.S. FDA Approval of Herbal Based Drugs

Date: November 20, 2012, 6:00pm to 8:00pm

Location: The Westin Taipei

Tulip Room

133, Nanjing East Road, Section 3, Taipei, Taiwan 10487

Price: $37 (USD)

Refreshments: Buffet and drinks

Seminar Description:

Experts from Amarex Clinical Research will give two presentations (with

an extended question and answer time) on strategies to achieve U.S.

FDA approval for herbal medicines to be sold as prescription drugs and

herbal foods and supplements to be sold into the U.S. market.


Presentation One:

Strategies for U.S. FDA Approval of Herbal Medicines and Herbal


* by Dr. Mukesh Kumar


Presentation Two:

Adaptive Clinical Trial Designs for Herbal Testing

* by Dr. Kazem Kazempour, Sr. Director of Biometrics

(See expanded talk descriptions below)


Registration: Prepayment Required; Limited Space; Two persons per

company please

Go to:


For additional information: Ms. Michelle Salaum, Amarex Clinical




Amarex is a global Contract Research Organization (CRO) that provides

clinical product development services to bioscience companies to

achieve FDA approval for their new medical products. These services

include: 1) product development strategy creation, 2) pre-clinical and


clinical trial conduct, and 3) applications to the FDA for marketing

approval of new medical products.


Presentation Details

ŸFDA acceptable definition and main characteristics of herbal


ŸThe US herbal medicine market and the main causes for the

increased interest in herbal medicines

ŸFDA acceptable practices for manufacture and marketing of herbal


ŸAdaptive clinical trials to evaluate the efficacy and safety of herbal


ŸUsing non-US marketing and medical experience support US IND for

herbal products

ŸPossible solutions for common manufacturing issues with

herbal/botanical drugs

ŸFDA approval of herbal drugs

ŸConclusions and future directions


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