U.S. FOOD AND DRUG ADMINISTRATION: Technetium Tc99m Succimer Injection (DMSA)
Technetium Tc99m Succimer Injection (DMSA) is currently in shortage
Latest News
U.S. FOOD AND DRUG ADMINISTRATION: The agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue
U.S. FOOD AND DRUG ADMINISTRATION: FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
U.S. FOOD AND DRUG ADMINISTRATION: FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products
Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD).
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs
We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
Access to affordable insulin can be a matter of life and death for Americans with diabetes.
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.
FDA clears Selvita to conduct Phase 1 study for acute myeloid leukemia
The FDA will allow Selvita to conduct a Phase 1 study on an Investigational New Drug for acute myeloid leukemia or high-risk myelodysplastic syndrome.
U.S. FOOD AND DRUG ADMINISTRATION: CELLDYN Emerald Class 2 Device Recall
Class 2 Device Recall CELLDYN Emerald
U.S. FOOD AND DRUG ADMINISTRATION: PalTop Class 2 Device Recall
Class 2 Device Recall PalTop
U.S. FOOD AND DRUG ADMINISTRATION: Isocarboxazid Tablets
Isocarboxazid Tablets is currently in shortage.
U.S. FOOD AND DRUG ADMINISTRATION: Azithromycin (Azasite) Ophthalmic Solution 1%
Azithromycin (Azasite) Ophthalmic Solution 1% is currently in shortage.
U.S. FOOD AND DRUG ADMINISTRATION: Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
U.S. FOOD AND DRUG ADMINISTRATION: Actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule
Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule
U.S. FOOD AND DRUG ADMINISTRATION: Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget
President’s Fiscal Year (FY) 2020 Budget request for the FDA
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U.S. FOOD AND DRUG ADMINISTRATION: New steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
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U.S. FOOD AND DRUG ADMINISTRATION: Efforts to promote and foster blood pathogen reduction technologies
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies
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U.S. FOOD AND DRUG ADMINISTRATION: On steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility
U.S. FOOD AND DRUG ADMINISTRATION: Calcitriol Injection USP 1MCG /ML
Calcitriol Injection USP 1MCG /ML is currently in shortage