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The goal of this short-course is to introduce the opportunities
and challenges associated with the introduction of generic drugs and
dietary supplements into the US marketplace. |
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(10:00 -
11:20) |
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Margaret Choy
Vice President of Regulatory Affairs
Anchen Pharmaceuticals |
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Abbreviated New Drug Applications |
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Since the Hatch-Waxman Act, a special route for the
submssions of generic drugs has been available that circumvents many
of the normal testing requirements for new drugs. This talk will focus
on the legislative and regulatory requirements for gaining approval
for a generic drug through the FDA. It will include an overview of
the patent requirements and timing needed to maximize market impact,
and will discuss the elements that are needed in an ANDA application. |
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(11:40 -
13:00) |
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Frances Richmond
Program Director of Regulatory Science
College of Pharmacy of University of Southern California |
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Presubmission biological testing of drug products(40
minutes) |
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Submission of an ANDA or 505(b)2 application depends
on having clinical and in some cases preclinical data that will be
accepted by the FDA. We will talk about the basic requirements for
such testing and will review various strategies for developing such
data either in the US, or in Asia. We will also talk about the role
of contract research organizations in the generation of data and management
of trials. |
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505 (b)2 Regulations in the US (40 minutes) |
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Over the past few years the landscape for modified
drugs has changed markedly. We will review the two areas that are
most challenging with regard to modified drugs; how to bring together
previously published literature and evidence with your evidence, and
how to decide on strategies for the submission. |
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(14:00 -
15:20) |
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Margaret Choy
Vice President of Regulatory Affairs
Anchen Pharmaceuticals |
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Drug Master Files for API and chemical firms |
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A pathway into the US market for some businesses is
found by providing active pharmaceutical or other ingredients for
drug products produced elsewhere for American or multinational companies
with sales in the US. We will talk about the needs for documentation,
including the development of master files. We will also discuss the
increasing pressure on quality management and audits of firms supplying
APIs. |
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(15:40 -
17:00) |
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Margaret Choy
Vice President of Regulatory Affairs
Anchen Pharmaceuticals |
Frances Richmond
Program Director of Regulatory Science College of Pharmacy of
University of Southern California |
Douglas D. Lee
President
FDAlink Regulatory Consulting |
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