Department of Health and Human Services December 11, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval-the Premarket Approval Supplement Decisionmaking Process; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Modifications to Devices Subject to Premarket Approval (PMA)the PMA Supplement Decision-Making Process.'' The purpose of this guidance is to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified.
Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance document entitled ``Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.'' This revised draft guidance is intended to assist the industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). The revised draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.'' This revised draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The revision of the draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.
New Animal Drugs for Use in Animal Feeds; Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter; and a revision to bacterial pathogen nomenclature.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
