Department of Health and Human Services February 2, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's report on the status of the studies sponsors have agreed to or are required to conduct.
Determination That SUSTIVA (Efavirenz) 300-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SUSTIVA (efavirenz) 300-milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for efavirenz 300-mg tablets, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 456h and 2567
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
New Animal Drugs for Use in Animal Feeds; Lasalocid
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM Alliance Nutrition, Inc. The supplemental NADA provides for the use of a lasalocid Type A medicated article containing 20-percent lasalocid activity per pound to make free-choice Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns an experimental study to test labeling statement alternatives for certain prescription and over-the-counter (OTC) drug product labeling.
Memorandum of Understanding Between the Food and Drug Administration, Duke University and Duke University Health System, Inc.
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA, Duke University (DU) and Duke University Health System, Inc. (DUHS). The purpose of the MOU is to establish the terms of collaboration between FDA, DU and DUHS to support shared interests and will begin with an initiative entitled: The FDA, DU and DUMC Elective Program.
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