Department of Health and Human Services March 9, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
CIBA Vision Corp.; Withdrawal of Color Additive Petitions
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of three color additive petitions (CAP 5C0278, CAP 5C0279, and CAP 5C0280) proposing that the color additive regulations be amended to provide for the safe use of Color Index (C.I.) Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as color additives in contact lenses.
Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcipotriene Ointment, 0.005%, if all other legal and regulatory requirements are met.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
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