Withdrawal: FDA's cGMP Regulation and Investigational New Drugs

GMP News No. 716

GMP News
3 May 2006
 

Withdrawal: FDA's cGMP Regulation and Investigational New Drugs

 
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 The agency points out, though, that future comments on the withdrawn rule will be considered in developing a final rule using the usual Administrative Procedure Act notice-and-comment procedures.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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