Department of Health and Human Services May 16, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Labeling Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cosmetic Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization
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.
Determination That MEPRON (Atovaquone) Tablets, 250 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that MEPRON (atovaquone) tablets, 250 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 atovaquone tablets, 250 mg.
Draft Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Labeling for Human Prescription DrugsDetermining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.'' This guidance is intended to help applicants and the review staff in the Center for Drug Evaluation and Research (CDER) at FDA determine when a drug belongs to an established pharmacologic class as well as how to select the appropriate word or phrase (term) that describes the pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling.
Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. Applicants are encouraged to use this guidance to design cancer clinical trials and to discuss protocols with the agency. This guidance provides background information and discusses general regulatory principles. Additional companion guidances will follow and will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. This guidance, and the subsequent indication-specific guidances, should speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims.
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