FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals
Category Archives: Drug Safety Information Podcasts
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).
FDA permits marketing of device to treat diabetic foot ulcers
FDA permits marketing of device to treat diabetic foot ulcers