other · Food and Drug Administration · Rule · Published 1998-12-31 · Effective 1999-02-02 · 63 FR 72171
Document
Document number
98-34546
Federal Register citation
63 FR 72171
CFR reference
21 CFR 54
Type
Rule
Action
Final rule; action on petition for reconsideration.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-12-31
Effective date
1999-02-02
HHS docket
Docket No. 93N-0445
Abstract
The Food and Drug Administration (FDA) is revising the requirements regarding financial disclosure by clinical investigators in order to add material to the codified language that was inadvertently omitted and to clarify the compliance dates to, in some cases, restrict the retroactive application of certain requirements of the rule. FDA is making these changes in order to respond to concerns raised by the Pharmaceutical Research Manufacturers Association (hereinafter referred to as ``PhRMA''). By making these changes, FDA will be reducing the administrative burden for manufacturers and other affected parties while, at the same time, ensuring that the agency obtains the information that is most relevant to its review of clinical data submitted in marketing applications.