Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that the Commissioner of Food and Drugs (the Commissioner) has concluded that certain commonly used positron emission tomography (PET) drugs, when produced under conditions specified in approved applications, can be found to be safe and effective for certain indications specified in this document. FDA announces the approval procedures for these PET drugs and indications and invites manufacturers of these drugs to submit applications for approval under this document. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is issuing a draft guidance for industry entitled "PET Drug Applications--Content and Format for NDA's and ANDA's," which is intended to assist manufacturers that submit applications for approval as specified in this document.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. 00N-0553] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that the Commissioner of Food and Drugs (the Commissioner) has concluded that certain commonly used positron emission tomography (PET) drugs, when produced under conditions specified in approved applications, can be found to be safe and effective for certain indications specified in this document. FDA announces the approval procedures for these PET drugs and indications and invites manufacturers of these drugs to submit applications for approval under this document. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal ( printed page 13000) Register , FDA is issuing a draft guidance for industry entitled “PET Drug Applications—Content and Format for NDA's and ANDA's,” which is intended to assist manufacturers that submit applications for approval as specified in this document. ADDRESSES: Submit applications for approval to the Center for Drug Evaluation and Research, Food and Drug Administration, 12229 Wilkins Ave., Central Document Room, Rockville, MD 20852. Copies of the published literature listed in the appendix to this document, FDA reviews of the literature, product labeling referenced in section IV of this docu…
Citation: 65 FR 12999
