[Federal Register Volume 60, Number 49 (Tuesday, March 14, 1995)]
[Notices]
[Page 13728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6199]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Comparing Treatments: Safety, Effectiveness, and Cost-
Effectiveness; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is holding a meeting to explore methodological and regulatory issues in 
the design and review of studies intended to show differences or 
similarities among active drug and biological therapies. As the 
pharmaceutical marketplace evolves, there are new pressures on the 
developers of drug/biological products to demonstrate comparative 
effects. This meeting will examine the needs for this type of 
information, how the pharmaceutical industry is responding to new 
demands for comparative information, case-study experience ruling out 
biases in study design, the use of observational studies, 
methodological concerns in effectiveness trials, and promotional 
considerations. The study will examine issues concerning evaluation of 
safety, effectiveness, and cost-effectiveness.

DATES: The meeting will be held on Thursday, March 23, 1995, 8 a.m. to 
5:30 p.m., and on Friday, March 24, 1995, 8:30 a.m. to 5 p.m.

ADDRESSES: The meeting will be held at the National Institutes of 
Health, Clinical Center, Bldg. 10, Jack Masur Auditorium, 9000 
Rockville Pike, Bethesda, MD. Copies of the transcript of the meeting 
will be available from the contact person listed below. There is no 
registration fee for this meeting. Interested persons are encouraged to 
register early because space is limited.

FOR FURTHER INFORMATION CONTACT: Regarding information concerning the 
meeting and registration forms: Louis A. Morris, Center for Drug 
Evaluation and Research (HFD-240), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6812, FAX 301-594-6759.

    Dated: March 8, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-6199 Filed 3-13-95; 8:45 am]
BILLING CODE 4160-01-F