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Our firm helps
commercial and academic organizations navigate their
course through the FDA laws, regulations and guidelines
that are required for success within this highly
regulated and challenging environment.
We specialize in the
manufacture of products made or associated with
cell-based technology:
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Recombinant
Proteins. |
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Monoclonal
Antibodies. |
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Gene Therapy and
Cell Therapy. |
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Stem Cells. |
This website includes
information about our consulting services and other
information that may be of benefit to our clients.
The following is a general discussion of the FDA's
manufacturing requirements:
US manufacture of
pharmaceutical and biopharmaceutical products must
comply with defined minimum standards set forth by the
FDA. These standards are contained within specific
Federal Laws:
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The Federal Food
Drug and Cosmetic (FDC) Act (1938 - Drugs and
Biologics). |
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The
Public Health Service Act (1944 –
Biologics). |
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Medical
Device Amendments (1976).
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These laws are
delineated in regulations (US Code of Federal
Regulations), which have the force of law and may be
enforced by the FDA through the Federal Court System.
For example:
The FDA provides
guidelines to assist manufacturers in understanding
these laws and regulations. While the guidelines
are "voluntary" in principle, they represent
both the FDA's
current interpretation of the regulations and
the FDA's expectations for industry compliance.
Companies or academic
organizations that operate within the state of
California must also comply with the California Health
and Safety Code Section:
Sherman Food,
Drug, and Cosmetic Laws. This law requires a CA
Drug Manufacturing License (drugs and biologics) or a CA
Medical Device Manufacturing License for all
manufacturers, prior to shipment of their first human
use product. There is no exception for clinical
manufacturing. These licenses may only be
obtained following an on-site inspection conducted by
the FDB (Food and Drug Branch of the CA Department of
Health Services). We assist our California clients
in preparing for this inspection.
Articles to Download:
Gene Therapy / Cell Therapy / Stem Cells – Regulations
for the "New Biologics"; Abstract and Presentation by
W.R. Tolbert at the March 30, 2007 AOAC-SCS
Regulatory & Compliance Conference
Back to the Future: Today’s innovators are breaking new
ground, just as we did three decades ago. This time,
the process is accelerated, as scientists learn from the
past - W.R. Tolbert, BioPharm International, October
2007.
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