[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32482-32483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13769]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. FDA-2010-N-0247]




Investigational New Drug Applications; Co-development of 

Investigational Drugs



AGENCY: Food and Drug Administration, HHS.



ACTION: Notice; establishment of docket; request for comments.



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SUMMARY: The Food and Drug Administration (FDA) is establishing a 

public docket to obtain input on methods to co-develop two or more 

distinct investigational drugs intended to be used in combination to 

treat a disease or condition. FDA is planning to develop guidance for 

industry and other affected parties on the co-development of two or 

more novel drugs intended to be used in combination (but not as not 

fixed-dose combinations) and is seeking public input to identify the 

affected parties' information needs concerning such co-development. 

Accordingly, FDA is seeking comment on general methodologic and 

regulatory issues that arise in various scenarios when co-developing 

two or more investigational drugs intended to be used in combination. 

FDA is also seeking comment on methodologic and regulatory issues when 

co-developing two or more investigational drugs intended to be used in 

combination for specific therapeutic areas, including oncology, anti-

infectives, seizure disorders, cardiovascular diseases, and any other 

therapeutic category in which such co-development is likely to occur.



DATES: Submit either electronic or written comments by September 7, 

2010.



ADDRESSES:  Submit written comments to the Division of Dockets 

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 

rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.



FOR FURTHER INFORMATION CONTACT: Colleen L. Locicero, Center for Drug 

Evaluation and Research, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4200, Silver Spring, MD 20993-0002, 301-

796-2270.



SUPPLEMENTARY INFORMATION:



I. Background



    FDA is aware of growing interest in co-developing two or more 

distinct, novel investigational drugs intended to be used in 

combination to treat a disease or condition (but not as fixed-dose 

combinations under 21 CFR 300.50). At a September 2009 conference co-

hosted by the ``Friends of Cancer Research'' in partnership with the 

Engelberg Center for Health Care Reform at the Brookings Institution, 

and supported by the American Society for Clinical Oncology (ASCO), the 

American Association for Cancer Research (AACR) Susan G. Komen for the 

Cure, and the Lance Armstrong Foundation (Brookings Conference), which 

was attended by FDA scientists, there was considerable interest in 

approaches to developing new oncology therapies intended to be used in 

combination. In addition, on April 30, 2010, FDA held a public hearing 

in accordance with part 15 (21 CFR part 15) devoted, in part, to 

obtaining information about study designs and appropriate populations 

for developing two or more novel, direct-acting antivirals intended to 

be used in combination for the treatment of chronic hepatitis C. FDA is 

also aware of efforts to try to develop two or more investigational 

drugs intended to be used in combination to treat tuberculosis. FDA is 

further aware of general uncertainty about the evidentiary requirements 

and regulatory criteria applicable to such co-development efforts. 

Accordingly, FDA is planning to develop generally applicable guidance 

(not restricted to oncology or any other specific therapeutic category) 

to address



[[Page 32483]]



methodologic and regulatory issues related to the co-development of two 

or more investigational drugs intended to be used in combination.



II. Issues on Which FDA is Seeking Comment



    All material submitted to this docket will be publicly available. 

To facilitate development of guidance that meaningfully addresses the 

concerns of those who may co-develop drugs intended to be used in 

combination, FDA is seeking input on the following issues, and any 

other issues relevant to developing FDA guidance:

    1. General methodologic and regulatory issues that arise in the co-

development of two or more drugs intended to be used in combination 

where the drugs are directed at providing a therapeutic effect on the 

same symptom or manifestation of the disease or condition of interest, 

including relevance and utility of clinical or animal findings for 

either drug alone;

    2. General methodologic and regulatory issues that arise in the co-

development of two or more drugs intended to be used in combination 

where the drugs are directed at providing a therapeutic effect for the 

same disease or condition, but act on different symptoms or 

manifestations of that disease or condition, including relevance and 

utility of clinical or animal findings for either drug alone;

    3. General methodologic and regulatory issues that arise in the co-

development of two or more drugs intended to be used in combination 

where one or more of the drugs is intended to enhance the effectiveness 

of the other, but one or more of the drugs does not or may not have an 

independent therapeutic effect, including relevance and utility of 

clinical or animal findings for either drug alone; and

    4. Methodologic and regulatory issues that arise in the co-

development of two or more drugs intended to be used in combination for 

specific therapeutic categories, including oncology, anti-infectives, 

seizure disorders, cardiovascular diseases, and any other therapeutic 

category in which such co-development is likely to occur.



III. Submission of Comments



    Interested parties may submit to the Division of Dockets Management 

(see ADDRESSES) either electronic or written comments regarding this 

document. It is only necesary 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.



    Dated: June 2, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-13769 Filed 6-7-10; 8:45 am]

BILLING CODE 4160-01-S