[Federal Register Volume 64, Number 130 (Thursday, July 8, 1999)]
[Notices]
[Pages 36886-36887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17331]
[[Page 36886]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1938]
Review of Guidances for Industry on the Development of Generic
Drug Products; Development and Use of FDA Guidance Documents; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER), Office of Generic Drugs (OGD) is
providing notice to drug manufacturers on its plans for reviewing
policy and procedure guides (PPG's) and other existing OGD documents
that provide guidance on the development of generic drug products. This
effort is being undertaken consistent with the agency's good guidance
practices (GGP's) policy. The goal of this long-term effort is to
identify documents that need to be revised, reformatted to fit the GGP
policy, or withdrawn because they are no longer current. OGD hopes this
process will result in guidances for industry that better reflect the
current thinking of the agency on generic drug development. OGD also is
seeking input from the public on topics for future guidance
development.
DATES: Written comments by September 7, 1999. General comments on
agency guidance documents are welcome at any time.
ADDRESSES: Copies of agency guidance documents can be obtained on the
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit
written comments to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rita R. Hassall, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-5845.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 27,
1997 (62 FR 8961), FDA published a notice explaining its policy for
guidance document development, issuance, and use. The notice included
an agency document entitled ``Good Guidance Practices'' (GGP's), which
sets forth agency policies and procedures for developing, issuing, and
using guidance documents.
Since the early 1990's, OGD has developed and issued more than 40
PPG's to provide information to industry on the development of generic
drug products and to set forth procedures for the review of generic
drug applications. In addition, other guidance has been provided in the
form of letters and other communications to industry. OGD is
undertaking a long-term effort to review all of its guidances and
identify those that need to be revised, those that need to be
reformatted for consistency with GGP's, and those that need to be
withdrawn because they are no longer current. As an initial step in
this process, OGD is planning to withdraw a number of drug-specific
bioequivalence guidances that are outdated and no longer reflect the
current thinking of the agency. Guidances that are being withdrawn
include the following:
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Guidance Date of Issuance
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Alprazolam (tablets) November 27, 1992
Bumetanide (tablets) April 23, 1993
Captopril (tablets) May 13, 1993
Carbidopa and Levodopa (tablets) June 19, 1992
Cefaclor (capsules and suspension) April 23, 1993
Diflunisal (tablets) May 16, 1992
Diltiazem Hydrochloride (tablets) May 16, 1992
Flurbiprofen (tablets) June 8, 1995 (2d Revision)
Gemfibrozil (tablets and capsules) June 15, 1992 (Revision)
Guanabenz Acetate (tablets) April 23, 1993
Hydroxychloroquine Sulfate December 28, 1995
(tablets)
Indapamide (tablets) April 23, 1993
Ketoprofen (capsules) April 23, 1993
Leucovorin Calcium (tablets) August 4, 1988 (Revision)
Medroxyprogesterone Acetate September 17, 1987 (Revision)
(tablets)
Metoprolol Tartrate (tablets) June 12, 1992
Nadolol (tablets) May 16, 1992
Naproxen (tablets) June 8, 1995 (Revision)
Nortriptyline Hydrochloride June 12, 1992
(capsules)
Pentoxifylline (extended-release December 22, 1995
tablets)
Pindolol (tablets) April 23, 1993
Piroxicam (capsules) June 15, 1992
Ranitidine Hydrochloride (tablets) April 23, 1993
Trazodone Hydrochloride (tablets) April 30, 1988 (Revision)
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It is possible that some of the remaining drug-specific guidances on
bioavailability and bioequivalence also will be withdrawn after they
are reassessed. However, several CDER guidances currently under
development will serve as core guidances on bioavailability and
bioequivalence once they have been finalized, and they will replace the
product-specific guidances. On rare occasions, the agency may wish to
provide bioavailability and bioequivalence guidance for specific drug
products, and these will be developed and issued consistent with the
agency's GGP policy.
The agency welcomes public comment on its efforts to review
existing guidances related to the development of generic drugs and
revise, reformat, or withdraw them as appropriate. The agency also is
requesting public comment on topics for future guidance development
regarding generic drugs.
This information is being issued consistent with FDA's GGP's. It
does not
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create or confer any rights for or on any person and does not operate
to bind FDA or the public.
Interested persons may submit written comments to the Dockets
Management Branch (address above). Two copies of any 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 document. Received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-17331 Filed 7-7-99; 8:45 am]
BILLING CODE 4160-01-F