Department of Health and Human Services March 25, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Decision To Evaluate a Petition To Designate a Class of Employees for Revere Copper and Brass in Detroit, MI, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 3.12(e) of a decision to evaluate a petition to designate a class of employees for Revere Copper and Brass in Detroit, Michigan, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Determination That DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DIDREX (benzphetamine hydrochloride (HCl)) Tablets, 25 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for benzphetamine HCl 25 mg tablets, if all other legal and regulatory requirements are met.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop
The Food and Drug Administration (FDA) Los Angeles District Office, in cosponsorship with the Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices.'' The public workshop is intended to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among the FDA and clinical trial staff, investigators, and ivestigational review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents, and regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors.
Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), and more specifically, this guidance provides information to the industry on submitting a single reportable food report to FDA covering reportable food located at more than one of a company's facilities.
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