2011-2313. Positron Emission Tomography; Notice of Public Meeting; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public meeting to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in positron emission tomography (PET) imaging. By December 12, 2011, FDA expects all producers of PET drugs in commercial clinical use to submit applications for marketing approval. FDA recognizes that many PET drug producers are unfamiliar with the drug approval process. Accordingly, FDA is holding this public meeting to discuss the drug approval process and FDA's general inspection process. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a revised draft guidance for industry entitled “PET Drug Applications—Content and Format for NDAs and ANDAs” that will be used at the meeting to explain the drug approval process.

DATES:

The meeting will be held on March 2, 2011, from 8:30 p.m. to 5 p.m. See section IV of this document for information on how to register for and attend the meeting. Submit either electronic or written comments on this document by March 7, 2011.

ADDRESSES:

The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993-0002.

Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Giaquinto, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6164, Silver Spring, MD 20993-0002, 301-796-3416, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

On November 21, 1997, President Clinton signed the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) (FDAMA) into law. Section 121(c) of FDAMA directs FDA to regulate PET drugs. Section 121 requires FDA to develop appropriate procedures for the approval of PET drugs as well as current good manufacturing practice (CGMP) requirements for such drugs; to consult with patient advocacy groups, professional associations, manufacturers, and persons licensed to make or use PET drugs in the process of establishing these procedures and requirements; and to not require the submission of NDAs or ANDAs for compounded PET drugs that are not adulterated as described in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for a period of 4 years after the date of enactment of FDAMA or 2 years after the date FDA adopts special approval procedures and CGMP requirements for PET drugs, whichever is longer.

Beginning in 1997, FDA took a series of actions to regulate PET drugs.

• The Agency conducted several public meetings with various representatives of an industry trade association, the Academy for Molecular Imaging (formerly the Institute for Clinical PET (ICP)), and other interested persons to discuss FDA proposals for PET drug approval procedures and CGMP requirements. Because certain PET drugs have been used clinically for a number of years, FDA conducted its own review of the published literature ^[1] to evaluate the safety and effectiveness of the PET drugs in widespread use for certain indications to facilitate the process of submitting applications for these products.

• The Agency discussed its preliminary findings on the safety and effectiveness of FDG F 18 injection (for the assessment of malignancy as well as left ventricular myocardial viability) and ammonia N 13 injection (for assessing myocardial perfusion) with the ICP and other interested persons at public meetings on November 17, 1998, and February 18 and 19, 1999.
• On June 28 and 29, 1999, the Agency presented its findings to its Medical Imaging Drugs Advisory Committee (Advisory Committee). The Advisory Committee concluded that FDG F 18 injection and ammonia N 13 injection can be considered safe and effective for the indications noted previously, although it recommended some revisions to the wording of the indications proposed by FDA.
• In a notice published in the Federal Register of March 10, 2000 (65 FR 12999), FDA presented its findings of safety and effectiveness for the PET drugs studied for certain indications and described the types of applications that can be submitted for FDG F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging. These findings fulfill the requirement to develop appropriate approval procedures for these PET drugs.
• In the Federal Register of April 1, 2002, FDA published a preliminary draft proposed CGMP regulation (67 FR 15344) and a draft guidance on CGMP requirements (67 FR 15404) for public comment; in the Federal Register of September 20, 2005, FDA published a proposed rule (70 FR 55038) and revised draft guidance (70 FR 55145), to solicit additional public input; in the Federal Register of December 10, 2009 (74 FR 65409), after carefully considering all public input, FDA published a final CGMP regulation, triggering the 2-year time period for PET drug producers to submit an NDA or ANDA for any PET drug used clinically.

FDA is in the process of establishing a time line for completion of the review of PET drug applications and approval determinations. PET drug application submissions must be received by the Agency on or before December 12, 2011. Applicants may continue to use a PET drug during the time of our NDA or ANDA review. FDA intends to exercise enforcement discretion regarding unapproved PET drugs while submissions are reviewed. However, FDA expects that by December 9, 2015, all PET drugs in commercial clinical use (i.e., not used under a Radioactive Drug Research Committee or an investigational new drug application (IND)) will be used under approved applications and does not intend to exercise enforcement discretion beyond that date.

II. PET Guidances

Elsewhere in this issue of the Federal Register, FDA is making available a revised draft guidance for industry entitled “PET Drug Applications—Content and Format for NDAs and ANDAs.” The draft guidance provides background information on the regulation of PET drugs; makes recommendations to help producers decide whether to submit an NDA or ANDA for their PET drug; includes a description of the content and format for both an NDA and an ANDA; and provides text that may be used in the applications.

More information on CGMP requirements for PET drugs may be found in the guidance for industry entitled “PET Drugs—Current Good Manufacturing Practice (CGMP)” issued December 2009, available at http://www.fda.gov/​downloads/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​UCM070306.pdf.

III. Purpose and Scope of the Meeting

The purpose of this meeting is to assist applicants in preparing NDA and ANDA submissions for specific PET drugs: FDG F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection. FDA will present information designed to assist PET drug producers with the entire application process. FDA expects to discuss the following topics at the public meeting:

• Whether to submit an NDA or ANDA,
• Preparing and submitting an NDA,
• Preparing and submitting an ANDA,
• Bioequivalence requirements,
• Labeling,
• User fees,
• Drug Master Files,
• Compliance with CGMPs, and
• INDs.

The Office of Critical Path Programs is preparing a separate training session on electronic submission of applications and electronic drug registration and listing for PET drug producers. The training will be offered via webinar and will be made available at several different times. Therefore, these topics will not be addressed at the March 2, 2011, meeting. For more information on this training and its availability, please contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT).

IV. Registration and Attendance

The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating, therefore early arrival is encouraged. Attendance is free and will be on a first-come, first-served basis. For more information on meeting registration, contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT).

If you need special accommodations because of a disability, please contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

A live Web cast of this meeting will be available on the Agency's Web site at https://collaboration.fda.gov/​petdrugs/​ on the day of the meeting. For more information on the Web cast and Connect Pro meeting, please contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT).

V. Comments

Regardless of attendance at the public meeting, interested persons may submit to the Division of Docket Managements (see ADDRESSES) either electronic or written comments on the topics discussed in this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday.

VI. Transcripts

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

Dated: January 28, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

Footnotes

1.  As stated in FDA guidance for industry entitled “Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products,” FDA may, in certain circumstances, rely on published literature alone to support the approval of a new drug product under section 505 of the FD&C Act (21 U.S.C. 355).