[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Notices]
[Pages 12218-12219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6410]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97N-0083]
Abbreviated New Drug Applications; Positron Emission Tomography
Radiopharmaceuticals; Notice of a Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to provide information to the positron emission tomography
(PET) radiopharmaceutical industry on submitting abbreviated new drug
applications (ANDA's) and other regulatory issues affecting PET
radiopharmaceutical drug products. The workshop will provide guidance
on topics such as ANDA regulatory requirements, registration and
listing requirements, chemistry and manufacturing controls, sterility
assurance, bioequivalence requirements, and labeling. An agenda and
materials to be discussed at the workshop will be available before the
workshop.
DATES: The workshop will be held on Monday, April 28, 1997, from 8 a.m.
to 5 p.m. Because space is limited, interested persons are encouraged
to register as soon as possible. Preregistration will be accepted
through April 18, 1997. There is no registration fee for the workshop.
The administrative docket will remain open until June 27, 1997, to
receive written comments, data, information, or views on the workshop
and materials distributed at the workshop.
ADDRESSES: The workshop will be held at the Parklawn Bldg., 5600
Fishers Lane, conference rm. D, Rockville, MD 20857. Persons interested
in attending should pre-register by faxing their name, title,
organization name if any, address, telephone and fax numbers to the
contact person. Registrants' fax numbers should be provided, so that
registration can be confirmed by return fax.
Before the workshop, the agenda and materials to be discussed at
the workshop will be available via the Internet using the World Wide
Web (WWW). To connect to the Center for Drug Evaluation and Research
(CDER) Home Page, type http://www.fda.gov/cder and go to the ``What's
Happening'' section. A transcript of the workshop will be available
from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, approximately
15 business days after the workshop at a cost of 10 cents per page.
Written comments on the workshop or materials discussed at the
workshop can be submitted until June 27, 1997, to the Dockets
Management Branch (HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857. Two copies of comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this notice. Received
comments may be viewed at the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Susan C. Lange, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-160), 5600
Fishers Lane, Rockville, MD 20857, 301-443-0260, FAX 301-594-0746.
SUPPLEMENTARY INFORMATION:
I. Background
PET is a diagnostic imaging modality consisting of onsite
production of radionuclides that are usually intravenously injected
into patients for diagnostic purposes. The potential usefulness of a
PET radiopharmaceutical is based upon the product's interaction with a
biochemical process in the body.
Over the last 20 years, there has been increasingly widespread
commercial use of a growing number of PET radiopharmaceuticals. Having
considered the available information, including that presented to the
agency at a March 1993 hearing and in written materials, in the Federal
Register of February 27, 1995 (60 FR 10593), FDA provided additional
notice and guidance to the industry stating how the agency would apply
its regulatory authority to PET drug products.
Since the approval of one new drug application for F-18 FDG, PET
drug product manufacturers have sought information on the submission of
ANDA's. Details of the ANDA submission process will be discussed at the
workshop. Other topics to be addressed include registration and listing
requirements, chemistry and manufacturing controls, sterility
assurance, bioequivalence requirements, labeling, and compliance with
current
[[Page 12219]]
good manufacturing practice regulations and other regulatory
requirements. Materials providing guidance on ANDA submissions and
related topics will also be discussed at the workshop.
Dated: March 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6410 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F
