Department of Health and Human Services September 20, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for MACUGEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for FUZEON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Public Availability of Labeling Changes in `Changes Being Effected' Supplements.'' The guidance announces to holders of a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), who intend to submit a ``Changes Being Effected'' supplement (CBE supplement) to make a postapproval labeling change, that FDA will make labeling revisions identified in a CBE supplement publicly available upon receipt of the supplement by FDA. The guidance does not have any bearing on supplements that relate to chemistry, manufacturing, and controls changes, nor does it expand the circumstances in which an ANDA holder may effect labeling changes via a CBE supplement.

The Food and Drug Administration (FDA) has determined the regulatory review period for CYDECTIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.