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federal_register: 98-34546

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
98-34546 Financial Disclosure by Clinical Investigators Rule 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. 1998-12-31 1998 12 https://www.federalregister.gov/documents/1998/12/31/98-34546/financial-disclosure-by-clinical-investigators https://www.govinfo.gov/content/pkg/FR-1998-12-31/pdf/98-34546.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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  • 2 rows from document_number in federal_register_agencies
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