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HHS - 21 CFR PART 99

DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

active, Most Current
Organization: HHS
Publication Date: 1 April 2018
Status: active
Page Count: 12
scope:

(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:

(1) Concerns the safety, effectiveness, or benefit of a use that is not included in the approved labeling for a drug or device approved by the Food and Drug Administration for marketing or in the statement of intended use for a device cleared by the Food and Drug Administration for marketing; and

(2) Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.

(b) This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request.

Document History

April 1, 2020
DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...
April 1, 2019
DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...
21 CFR PART 99
April 1, 2018
DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...
April 1, 2017
DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...
April 1, 2016
DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...
April 1, 2015
DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...
April 1, 2013
DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated: (1) Concerns the safety, effectiveness, or...

References

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