FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.
FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.
FDA announces new plan to advance the development of plant and animal biotechnology innovation
Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing […]
FDA permits marketing of a diagnostic test to aid in the determination of menopausal status
The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.
FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.
A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products
FDA warns website networks as part of global crack down for selling illegal pharmaceuticals
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements
The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the “Winning on Reducing Food Waste” initiative.
FDA and DHS announce partnership to address medical device cybersecurity threats
FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results
FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems