Positron Emission Tomography (PET)
Related Documents

On November 21, 1997, the President signed the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Section 121 of the Modernization Act included provisions that directed FDA to establish appropriate procedures for the approval of positron emission tomography (PET) drugs and appropriate current good manufacturing practice requirements for such drugs. FDA has begun developing those procedures and has established this site to provide information on these activities. If you have questions about implementation of this provision of the Modernization Act, you can contact Ms. Renee Tyson at 301-827-7510.

Drug Approvals

• UPDATE - New Fludeoxyglucose F 18 Injection PET Drug Approved in Less than 6 Months (8/6/2004)

Legislation

• Food and Drug Administration Modernization Act, Sec 121. Positron Emission Tomography

Federal Register Notices

• Guidances for Industry on Medical Imaging Drug and Biological Products; Availability (NOA) [TXT] [PDF] (6/16/2004)

• Current Good Manufacturing Practice For Positron Emission Tomography Drug Products; Preliminary Draft Proposed Rule; Availability (NOA) [Text] or [PDF] (4/1/2002)

• Draft Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability (NOA) [Text] or [PDF] (4/1/2002)

• Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products;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 ]  [Text] or [PDF] (3/10/2000)

• Positron Emission Tomography Drug Products; Safety and Effectiveness of Certain PET Drugs for Specific Indications [Text] or [PDF] (3/10/2000)

• Announcing availability of preliminary draft regulations on PET drug current good manufacturing practices (CGMPs) [HTML] or [PDF] (3/22/1999)

Guidances

• Developing Medical Imaging Drug and Biological Products  (NOA) [TXT] [PDF] (Issued 6/2004, Posted 6/18/2004)

  • Part 1: Conducting Safety Assessments [Word] or [PDF]

  • Part 2: Clinical Indications [Word] or [PDF]

  • Part 3: Design, Analysis, and Interpretation of Clinical Studies [Word] or [PDF]
     

• PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML] or [PDF]  (Issued 3/29/2002, Posted 3/29/2002)  

• PET Drug Applications - Content and Format for NDAs and ANDAs [HTML] or [Acrobat] (Issued 3/7/2000, Posted 3/7/2000)

  • Sample formats for chemistry, manufacturing, and controls sections [PDF] or [Word97]

  • Sample formats for labeling [Acrobat] or [Word97]

  • Sample formats for Form FDA 356h [PDF] or [Word97]

  • Sample formats for user fee Form FDA 3397 [PDF] or [Word97]

Talks

Public Meeting, May 21, 2002, 9 a.m., Rockville, Maryland  

• Informal Discussion of the Preliminary Draft Proposed Rule on Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography (PET) Drug Products and the Draft Guidance on CGMP for PET Drug Products.

Public Meeting, July 28, 2000, Gaithersburg, Maryland

• Informal Discussion of Literature Reviews of Safety and Efficacy Data for PET: 150-Water and 18F-Fluorodopa, July 28, 2000 (Updated 9/19/2000)

Public Meeting, March 22, 2000, Gaithersburg, Maryland

• Informal Discussion of PET Drugs: Approval Procedures (6/5/2000)

Eleventh Annual Pet Conference, October 26, 1999, Vancouver, Canada

• Regulatory Current Good Manufacturing Practices for PET Drugs Update, Tracy Roberts, M.S., Office of Compliance, CDER (6/5/2000)

• Regulatory Framework for the Submission of an Application, Cecelia Parise, R.Ph., Office of Generic Drugs, CDER (6/5/2000)

• Model Applications to Manufacture PET Drugs for Marketing, Ravindra K, Kasliwal, Ph.D, Office of New Drug Chemistry, CDER (6/5/2000)