PET Drug Applications - Content and Format for NDAs and ANDAs_2011

Description

On December 9, 2009, FDA issued a final current good manufacturing practice (CGMP) regulation for the production of positron emission tomography (PET) drugs.2Under the requirements of section 121 of the Food and Drug Administration Modernization Act (FDAMA), within two years following this publication date, an NDA or ANDA must be submitted for any PET drug marketed for clinical use in the United States. This guidance is intended to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging for the indications cited in Section III (below). FDA approval of an NDA or ANDA will make it possible to market these PET drugs for clinical use according to the requirements of the Federal Food, Drug, and Cosmetic Act (the Act).3

Scope & Applicability

Regulatory Context

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 21CFR314.94§ 314.94 Content and format of an ANDA.

  ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →

• 21CFR314.108§ 314.108 New drug product exclusivity.

  (a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read full regulation →

• 21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.

  (a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →

• 21CFR314.53§ 314.53 Submission of patent information.

  (a) Who must submit patent information. This section applies to any applicant who submits to FDA an NDA or an amendment to it under section 505(b) of the Federal Food, Drug, and Cosmetic Act and § 314.50 or a supplement to an approved NDA under § 314.70 , except as provided in paragraph (d)(2) of thRead full regulation →

• 21CFR314.420§ 314.420 Drug master files.

  (a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →

• 21CFR314.92§ 314.92 Drug products for which abbreviated applications may be submitted.

  (a) Abbreviated applications are suitable for the following drug products within the limits set forth under § 314.93 :Read full regulation →

• 21CFR314.93§ 314.93 Petition to request a change from a listed drug.

  (a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →

• 21CFR314.3§ 314.3 Definitions.

  (a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →

• 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

  (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →

• 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

  (a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →

• 21CFR320.24§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.

  (a) Bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods. FDA may require in vivo or in vitro testing, or both, to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products. Information on bioequivRead full regulation →

• CGMP/Positron Emission Tomography (PET) Drugs/Adulterated

  3D Imaging Drug Design and Development LLC

  2025-12-16

• CGMP/Positron Emission Tomography (PET) Drugs/Adulterated

  Brigham and Women’s Hospital Inc.

  2022-05-10

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