federal_register: 2011-2314
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-2314 | Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "PET Drug Applications-- Content and Format for NDAs and ANDAs." The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations. This draft guidance revises the draft guidance entitled "Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability," issued on March 10, 2000. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting to assist applicants in preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging. | 2011-02-03 | 2011 | 2 | https://www.federalregister.gov/documents/2011/02/03/2011-2314/draft-guidance-on-positron-emission-tomography-drug-applications-content-and-format-for-new-drug | https://www.govinfo.gov/content/pkg/FR-2011-02-03/pdf/2011-2314.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "PET Drug Applications-- Content and Format for NDAs and ANDAs." The draft guidance is intended to assist manufacturers of certain positron emission... |