U.S. FOOD AND DRUG ADMINISTRATION: Nelarabine (Arranon) Injection
Nelarabine (Arranon) Injection is currently in shortage
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FDA OK'd 272 drugs in March
The U.S. Food and Drug Administration approved 272 drug products in March, according to a list the agency published on Thursday.
U.S. FOOD AND DRUG ADMINISTRATION: Technetium Tc99m Succimer Injection (DMSA)
Technetium Tc99m Succimer Injection (DMSA) is currently in shortage
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
FDA approves new drug for multiple sclerosis
People who suffer from multiple sclerosis (MS) have a new hope of slowing the progression of their disease with the U.S. Food and Drug Administation’s (FDA) approval of a new drug.
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.
FDA studying ways to improve medical device safety
Silicone breast implants, metal rods to stabilize broken bones, heart valves made from the tissues of pigs and cows—modern medical technology is continually developing devices to implant in human bodies to improve health, quality of life, or appearance.
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
FDA Update: Which drugs are in short supply?
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
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