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- Public Inspection
Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document...
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color...
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for community-acquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers,...
Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public Workshop; Request for Comments
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is...