FDA Oversight of PET Drug Products -- Questions and Answers

Description

This guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that address nearly all aspects of the drug regulatory process, including application submission, review, compliance with current good manufacturing practices, inspections, registration and listing, and user fees.

Scope & Applicability

Regulatory Context

• 21CFR207.21§ 207.21 When must initial registration information be provided?

  (a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.Read full regulation →

• 21CFR212.110§ 212.110 How must I maintain records of my production of PET drugs?

  (a) Record availability. Records must be maintained at the PET drug production facility or another location that is reasonably accessible to responsible officials of the production facility and to employees of FDA designated to perform inspections.Read full regulation →

• 21CFR212.30§ 212.30 What requirements must my facilities and equipment meet?

  (a) Facilities. You must provide adequate facilities to ensure the orderly handling of materials and equipment, the prevention of mix-ups, and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adRead full regulation →

• 21CFR212.70§ 212.70 What controls and acceptance criteria must I have for my finished PET drug products?

  (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity, and, if appropriate, sterility and pyrogens.Read full regulation →

• 21CFR212.40§ 212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in?

  (a) Written procedures. You must establish, maintain, and follow written procedures describing the receipt, login, identification, storage, handling, testing, and acceptance and/or rejection of components and drug product containers and closures. The procedures must be adequate to ensure that the coRead full regulation →

• 21CFR212.50§ 212.50 What production and process controls must I have?

  You must have adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality, and purity.Read 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 →

• 21CFR314.81§ 314.81 Other postmarketing reports.

  (a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →

• 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.

  (a) Definitions. The following definitions of terms apply to this section:Read 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 →

• 21CFR212.60§ 212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?

  (a) Testing procedures. Each laboratory used to conduct testing of components, in-process materials, and finished PET drug products must have and follow written procedures for the conduct of each test and for the documentation of the results.Read full regulation →

• 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 →

• 21CFR314.92§ 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 →

• 21CFR312.2§ 312.2 Applicability.

  (a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended ( 42 U.S.C. 201 etRead full regulation →

• 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.

  (a) Changes to an approved NDA.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 →

• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded

  Darmerica, LLC

  2025-12-23

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

  3D Imaging Drug Design and Development LLC

  2025-12-16

• False & Misleading Claims/Misbranded

  Novo Nordisk Inc.

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• OTC/Unapproved New Drug/Misbranded

  Supergoop!

  2025-08-12

• OTC/Unapproved New Drug/Misbranded

  K & Care Organics

  2025-08-12

• OTC/Unapproved New Drug/Misbranded

  Fallien Cosmeceuticals Ltd. dba Fallene Ltd.

  2025-08-12

• False & Misleading Claims/Misbranded

  Sprout Pharmaceuticals, Inc.

  2025-06-10

• Failure to List/Misbranded

  Shenzhen Hengkaifeng Commerce and Trade Co., Ltd

  2025-05-27

• False & Misleading Claims/Misbranded

  Sarfez Pharmaceuticals, Inc.

  2025-05-20

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