federal_register: 06-9684

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

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document_number	title	type	abstract	publication_date	pub_year	pub_month	html_url	pdf_url	agency_names	agency_ids	excerpts
06-9684	Expanded Access to Investigational Drugs for Treatment Use	Proposed Rule	The Food and Drug Administration (FDA) is proposing to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The proposed rule is intended to improve access to investigational drugs for patients with serious or immediately life- threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies.	2006-12-14	2006	12	https://www.federalregister.gov/documents/2006/12/14/06-9684/expanded-access-to-investigational-drugs-for-treatment-use	https://www.govinfo.gov/content/pkg/FR-2006-12-14/pdf/06-9684.pdf	Health and Human Services Department; Food and Drug Administration	221,199	The Food and Drug Administration (FDA) is proposing to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment...

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