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CCH NetNews™ |
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(November 10, 2009)
Food and Drug Law |
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The Drug Enforcement Administration (DEA) is seeking information regarding locum tenens practitioners, those who substitute temporarily for another to perform medical services for a healthcare organization for a specified length of time, to clarify the requirements that apply to locum tenens practitioners, in light of the December 2006 Final rule, ¶40,287, that specified that only intrastate locations are subject to the exception for registration at separate locations. Any locum tenens practice that is conducted in a state other than the state in which the practitioner maintains a DEA registration is subject to a separate DEA registration. DEA Advance Notice of Proposed Rulemaking.
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A draft guidance revised to reflect technological changes resulting from the requirement in the FDAA Act of 2007 to submit drug establishment registration and drug listing information electronically was published by the FDA. Titled “SPL Standard for Content of Labeling Technical Qs & As,” the draft guidance provides recommendations for sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the structured product labeling (SPL) standard in extensible markup language (XML). FDA Notice.
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The comment period for the placement of 5-methoxy-N,N- dimethyltryptamine (5-MeO-DMT) and its salts into Schedule I of the Controlled Substances Act (CSA) as proposed by the Drug Enforcement Administration (DEA) was reopened for an additional 30-day period until November 27, 2009. The original 30-day comment period expired on September 21, 2009. Finalization of the DEA proposal would impose criminal sanctions and regulatory controls of Schedule I substances under the CSA for the manufacturing, distribution, and possession of 5-MeO-DMT. DEA Notice.
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A guidance to assist investigators in meeting their responsibilities to protect human subjects and to ensure the integrity of data during clinical investigations has been issued by the FDA. Titled Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators, ” the guidance clarifies the FDA's expectations regarding investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties. Recommendations include creating a plan with: (1) routine meetings with staff to review progress; (2) routine meetings with monitors; (3) procedure for timely correction of problems identified; (4) procedure for addressing medical and ethical issues that arise. FDA Notice
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