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FDA Rule and Companion Guidance Make Early
Stage Clinical Drug Development Safe and
Efficient July 18, 2008
DRUG
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The U.S. Food and Drug Administration today issued a
final regulation that makes early phase 1 clinical drug
development safe and efficient by enabling a phased
approach to complying with current good manufacturing
practice (CGMP) statutes and FDA investigational
requirements.

To facilitate this new approach, the regulation exempts
most phase 1 investigational drugs from the requirements
in 21 CFR part 211 — FDA will continue to exercise
oversight of the manufacture of these drugs under FDA’s
general statutory CGMP authority and through review of
investigational new drug (IND) applications.  A companion
guidance recommends an approach for complying with
CGMP statutory requirements such as standards for the
manufacturing facility and equipment, the control of
components, as well as testing, stability, packaging,
labeling, distribution, and recordkeeping.

“With this action, we are tailoring the CGMP requirements
to make them appropriate to the earliest stages of drug
development. This approach will ensure that these
investigational products can be developed as efficiently as
possible with the highest level of patient protection," said U.
S. Health and Human Services Deputy Secretary Tevi Troy.

When FDA originally issued CGMP regulations for drug
and biological products (21 CFR parts 210 and 211), the
agency stated that the regulations applied to all types of
pharmaceutical production, but explained in the preamble
to the regulations that FDA was considering proposing
regulations more appropriate for the manufacture of drugs
used in investigational clinical trials. The reason for this is
that certain requirements in part 211 are directed at the
commercial manufacture of products — such as
repackaging and relabeling of drug products, rotation of
stock, and maintaining separate facilities for manufacturing
and packaging.  These types of requirements may be
inappropriate to the manufacture of investigational drugs
used in phase 1 clinical trials, many of which are carried
out in small-scale, academic environments, typically
involving fewer than 80 subjects.

“The new rule and guidance are intended to assure that
manufacturers meet high standards for the safety of phase
1 drugs and biologics while removing unnecessary barriers
that can slow the development of these potentially life-
saving products,” said Rachel Behrman, M.D., associate
commissioner for clinical programs and director of FDA’s
Office of Critical Path Programs.

The guidance, CGMP for Phase 1 Investigational Drugs,
describes an approach manufacturers can use to
implement manufacturing controls that are appropriate for
the phase 1 clinical trial stage of development. The
approach described in this guidance reflects the fact that
some manufacturing controls and the extent of
manufacturing controls needed to achieve appropriate
product quality differ among the various phases of clinical
trials.

Manufacturers will continue to submit detailed information
about relevant aspects of the manufacturing process as
part of the IND application. The FDA may inspect the
manufacturing operation, suspend a clinical trial by placing
it on “clinical hold,” or terminate the IND if there is evidence
of inadequate quality control procedures that would
compromise the safety of an investigational product.