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Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products
… exercise enforcement discretion for certain regenerative medicine products with respect to the FDA’s investigational … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for … Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic …
FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
… Scientist recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs
… in FDA’s 2019 budget to lay the groundwork for the “Center of Excellence on Compounding for Outsourcing … with the National Academy of Science, Engineering, and Medicine (NASEM) and through the FDA's Centers of Excellence … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
… like the National Academy of Sciences, Engineering, and Medicine. We’ve partnered with U.S. agencies such as the … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement on new steps to advance innovation in medical device sterilization with ethylene oxide
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales
… and could be relied upon to prevent pregnancy. The FDA’s Center for Devices and Radiological Health conducted an … American Urogynecologic Society, the National Library of Medicine and others on this effort, which is known as the … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
… dollars a vial to $234. Another study from the Schaefer Center at USC found that “the average U.S. list price of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids
… risking addiction to cigarettes. The National Academy of Medicine report from earlier this year found that kids who … must. In closing, I want to commend the work done by our Center for Tobacco Products on this groundbreaking campaign. … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Actualización del coronavirus (COVID-19): La FDA ayuda a facilitar la telemedicina veterinaria durante la pandemia
… de nuestra nación, y de regular los productos de tabaco. … Center for Veterinary Medicine … La FDA anunció que tiene la intención de no …