The direct final rule published in January, 2006 (71 FR 2458) was
intended to revise the current good manufacturing practice (CGMP)
regulations for human drugs, including biological products, to exempt most
investigational "Phase 1'' drugs from complying with the requirements
in FDA's regulations (also see our news
from Feb. 09).
After receiving significant adverse comments about the proposed
revisions, the FDA now withdraws this direct final rule, effective
immediately. The agency points out, though, that future comments on the
withdrawn rule will be considered in developing a final rule using the
usual Administrative Procedure Act notice-and-comment procedures.
Prepared by:
Wolfgang Heimes
One behalf of the European Compliance Academy (ECA)
Source:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-4091.pdf
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