New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper
AGAWAM, MASS. — September 10, 2013 — New
Federal Food & Drug Administration (FDA) regulations have streamlined the governance
of combination products — medical devices embedded with pharmaceutical or
biologic components. A new white paper titled "Combination Products 3.0: Applying the New FDA Regulations
in 2013" discusses the implications for manufacturers. The
whitepaper is available to download at http://microtestlabs.com/combination-products-30.
Combination products are
a large and growing segment of the medical device market. Some analysts
estimate they represent over 30% of all new FDA product submissions.
"Over the last 10
years, FDA regulatory centers have struggled with the changes and challenges
that these new technologies present. For manufacturers, the convergence of
drugs, biologics, and devices has created both a host of regulatory issues —
and many exciting opportunities," according to Steven Richter, Ph.D,
President and Chief Scientific Officer of Microtest Laboratories, Inc., and
author of the new white paper.
The new FDA publication,
"21 CFR Part 4 — Current Good
Manufacturing Practice Requirements for Combination Products," revises
regulations by establishing different categories of products. These included
single-entity products (such as a drug-eluting stent) and co-packaged products
(such as a packaged syringe and pharmaceutical). The rules also distinguished
between a drug with a device, a biologic with a device, and a device with an
HCT/P.
The new white paper discusses,
in detail and example, how the new FDA rules guide a manufacturer into one of
two approaches, depending upon the characteristics of their product.
According to Dr.
Richter, "the FDA's new streamlined approach for regulating combination
products is a big step forward for the practitioner. It applies parts of both
the QSR and GMP quality systems in a way that makes sense for the unique
characteristics of each combination product. 21 CFR Part 4 closes the gaps in
the 2004 guidelines and succinctly clarifies the process for establishing
quality systems that ensure compliance and patient health and safety.”
Download the
new white paper, “Combination Products 3.0: Applying the New FDA Regulations
in 2013,” from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a
leader in testing services and contract manufacturing for the medical device,
pharmaceutical, and biotechnology industries.
Based in Agawam, Mass.,
the company provides expertise and flexible processes that enhance product
safety and security, accelerate time to market, and minimize supply chain
disruption. For more information about Microtest Laboratories, visit microtestlabs.com or call 1-413-786-1680
or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter
@MicrotestLabs at http://twitter.com/MicrotestLabs.
Labels: biologic, combination products, FDA, Federal Food & Drug Administration, manufacturers, Medical Devices, paper, pharmaceutical, white, whitepaper
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