Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written or electronic comments on the draft guidance by June 5, 2002.
On November 21, 1997, the President signed the Food and Drug Administration Modernization Act of 1997 (Modernization Act) (Public Law 105-115) into law. Section 121(c)(1)(A) of the Modernization Act directs us to establish appropriate approval procedures and CGMP requirements for PET drugs. Section 121(c)(1)(B) states that, in adopting such requirements, we must take due account of any relevant differences between not-for-profit institutions that compound PET drugs for their patients and commercial manufacturers of the drugs. Section 121(c)(1)(B) also directs us to consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists who make or use PET drugs as we develop PET drug CGMP requirements and approval procedures.
We presented our initial tentative approach to PET drug CGMP requirements and responded to numerous questions and comments about that approach at a public meeting on February 19, 1999. In the
After considering the comments on the preliminary draft regulations, we have decided to make several revisions to those regulations. Elsewhere in this issue of the
Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments on the draft guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. The draft guidance and the comments submitted to the docket may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain the document at http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ohrms/dockets/default.htm, or http://www.fda.gov/cder/fdama under “Section 121—PET (Positron Emission Tomography).”