Department of Health and Human Services January 27, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Ryan White HIV/AIDS Program Part D-Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth
The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement award from the previous grantee, Orlando Health, Incorporated's HUG-ME Program, to the Orange County Health Department, Orlando, Florida, that will ensure continuity of Part D HIV/AIDS care and treatment services without disruption to HIV/ AIDS-infected women, infants and children in Orange County and the surrounding areas.
Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practice; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2Current Good Manufacturing Practice (CGMP).'' This guidance recommends an alternative method for manufacturers to comply with FDA's CGMP regulations that require laboratory apparatus be calibrated at suitable intervals in accordance with established written specifications. The guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U.S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances.
Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Assessment of Abuse Potential of Drugs.'' This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.
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