As it announced at the beginning of June, the Food & Drug
Administration (FDA) has now withdrawn seven guidances, two of them for
revision. The guidances in question had been issued by the "Center for Drug
Evaluation and Research" (CDER), the "Center for Biologics
Evaluation and Research" (CBER) and by the "Center for Veterinary
Medicine" (CVM) or by several of them.As the reason for the
withdrawal, the Agency states that these guidances are inconsistent
with the "cGMP for the 21st Century" Initiative. According
to the FDA, many of the guidances were created before the new initiative
and do not comply with its defined objectives. By means of the initiative,
which was introduced in 2002, the FDA intends to promote innovations in
the field of production, to concentrate its resources and regulatory
attention on the manufacture of medicinal products as well as on the major
potential quality risks and to harmonise its regulatory approach.
The list of withdrawn guidances includes some surprises, e.g. BACPAC
I by CDER and CBER. Since 2001, this guidance was among the most
important documents concerning GMP and Regulatory Compliance in API
production. To many, also the withdrawal of the 2 "CMC Draft
Guidances" both for APIs and for finished drug products, which had
been published as late as 2003 and 2004 respectively, came as a surprise.
The withdrawn guidances include:
By CDER:
- Format and Content of the Chemistry, Manufacturing, and Controls
Section of an Application,
(February 1987)
By CDER and CBER:
- Submitting Documentation for the Stability of Human Drugs and
Biologics(February 1987)
- Stability Testing of Drug Substances and Drug Products (Draft), (June 1998)
- Drug Product: Chemistry, Manufacturing, and Controls Information
(Draft), (January 2003)
- Submission of Chemistry, Manufacturing and Controls Information for
Synthetic Peptides,
(November 1994)
The following guidances were withdrawn by CVM for revision (and
therefore taken from the CDER and CBER websites):
- BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Post-approval
Changes: Chemistry, Manufacturing, and Controls Documentation(February 2001)
- Drug Substance: Chemistry, Manufacturing, and Controls Information
(draft), (January 2004)
Interestingly, CVM (not CBER and CDER!!) is planning to publish revised
versions of both documents. For BACPAC I, this has already been done.
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