[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
