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 Dr. Galson - “This new product will offer a much needed treatment option for patients suffering from this rare illness that, in some cases, has been found to progress to fatal forms of leukemia.”
 Dr. Galson - “This has the potential to improve the quality of life for millions of Americans with diabetes.”
 Steven Galson - “This product has the potential to improve the quality of life for millions of Americans.”
 Steven Galson - “This is a very highly innovative product that will improve the quality of life for millions of Americans with diabetes.”
 Steven Galson - “There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality. These products are not approved by the FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them.”
 Steven Galson - “There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality. These products are not approved by FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them.”
 Dr. Galson - “There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality.”
 Steven Galson - “Doug's medical, regulatory and leadership skills make him an outstanding addition to CDER's senior management team and I am honored that he has agreed to continue as my deputy. Doug has brought invaluable leadership and support to me and others in the Agency and I'm confident that he will continue to do an outstanding job working to protect and advance public health.”
 Dr. Galson - “The doctors who perform approximately 2,200 heart transplants in the U.S. each year will now have a new option for enhancing successful outcomes.”
 Steven Galson - “Until today, patients with diabetes who need insulin to manage their disease has only one way to treat their condition.”
 Steven Galson - “The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with health care providers and patients the latest serious reports of infection associated with this drug that we have received,”
 Dr. Galson - “It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.”
 Dr. Galson - “Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition. It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.”
 Dr. Galson - “Before beginning any human trials, the sponsor must perform extensive animal toxicity studies. Animal studies provide guidance on initial dosing and point to areas of safety needing special attention during human studies.”
 Steven Galson - “This approval is a welcome addition to the available defenses against the flu. This new use offers the medical community another option to prevent and control influenza A and B.”
 Steven Galson - “We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer. Patients need as many effective treatment options as possible.”
 Steven Galson - “Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer.”
 Dr. Galson - “This approval is another example of the benefits of the Orphan Drug program, which provides incentives for the development of treatments for diseases affecting fewer than 200,000 patients in the United States a year. Until now, Pompe disease has had no approved treatment.”
 Dr. Galson - “This approval is another example of the benefits of the Orphan Drug program. Until now, Pompe disease has had no approved treatment.”
 Dr. Galson - “This approval is a welcome addition to the available defenses against the flu.”
 Dr. Galson - “Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult-to-treat forms of cancer.”
 Steven Galson - “This approval is another example of the benefits of our agency's orphan drugs program, which seeks to answer the medical needs of small groups of patients. The doctors who perform approximately 2,200 heart transplants in the U.S. each year will now have a new option for enhancing successful outcomes by preventing the rejection of the grafted organs.”
 Dr. Galson - “This approval is another example of the benefits of our agency's 'orphan' drugs program, which seeks to answer the medical needs of small groups of patients. The doctors who perform approximately 2,200 heart transplants in the U.S. each year will now have a new option for enhancing successful outcomes by preventing the rejection of the grafted organs.”
 Dr. Galson - “Phase 2 studies are typically well controlled and closely monitored and may involve up to several hundred patients. At the conclusion of these studies, FDA (Food and Drug Administration) and the sponsor usually meet to determine how the drug's development should be studied in Phase 3 and how to design and conduct further trials.”
 Dr. Galson - “FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications. We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients.”

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