Department of Health and Human Services December 2, 2011 – Federal Register Recent Federal Regulation Documents

National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-31055
Type: Notice
Date: 2011-12-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2011-31050
Type: Notice
Date: 2011-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-31049
Type: Notice
Date: 2011-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-31048
Type: Notice
Date: 2011-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability
Document Number: 2011-31022
Type: Notice
Date: 2011-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft guidance also provides information about the data that should be submitted to support the appropriate classification of a co-crystal and the regulatory implications of the classification.
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