Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
: FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food
FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products
The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care
Federal judge enters consent decree against Delta Pharma
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act
FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.
FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.
FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.
FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry