95-1436. Adverse Experience Reporting Requirements for Human Drug; Correction
[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Proposed Rules]
[Pages 4131-4132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1436]
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[[Page 4132]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310
[Docket No. 93N-0181]
Adverse Experience Reporting Requirements for Human Drug;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a
proposed rule that appeared in the Federal Register of October 27, 1994
(59 FR 54046). The document proposed to amend its current adverse
experience reporting regulations for human drug products and for
licensed biological products. The document was published with an error
in the codified section. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Howard P. Muller, Center for Drug
Evaluation and Research (HFD-362), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1049.
In FR Doc. 94-26483, appearing on page 54046 in the Federal
Register of October 27, 1994, the following correction is made:
Sec. 310.305 [Corrected]
On page 54056, in the second column, in Sec. 310.305, paragraph
(b)(2) is corrected to read as follows:
Sec. 310.305 Records and reports concerning adverse drug experiences
on marketed prescription drugs for human use without approved new drug
applications.
* * * * *
(b) * * *
(2) Adverse drug experience means any adverse event associated with
the use of a drug in humans, whether or not considered drug related,
including the following: An adverse event occurring in the course of
the use of a drug product in professional practice; an adverse event
occurring from drug overdose, whether accidental or intentional; an
adverse event occurring from drug abuse; an adverse event occurring
from drug withdrawal; and any failure of expected pharmacological
action.
* * * * *
Dated: January 5, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-1436 Filed 1-19-95; 8:45 am]
BILLING CODE 4160-01-F
Document Information
- Published:
- 01/20/1995
- Department:
- Food and Drug Administration
- Entry Type:
- Proposed Rule
- Action:
- Proposed rule; correction.
- Document Number:
- 95-1436
- Pages:
- 4131-4132 (2 pages)
- Docket Numbers:
- Docket No. 93N-0181
- PDF File:
-
95-1436.pdf
- CFR: (1)
- 21 CFR 310.305