U.S. FOOD AND DRUG ADMINISTRATION: Belatacept (Nulojix) Lyophilized Powder for Injection
Belatacept (Nulojix) Lyophilized Powder for Injection is currently in shortage.
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U.S. FOOD AND DRUG ADMINISTRATION: Abciximab (ReoPro) Injection
Abciximab (ReoPro) Injection is currently in shortage.
U.S. FOOD AND DRUG ADMINISTRATION: FilterFlow Suction Handle
Class 2 Device Recall FilterFlow Suction Handle
U.S. FOOD AND DRUG ADMINISTRATION: Nelaton Urinary Catheter Class 2 Device Recall
Class 2 Device Recall Nelaton Urinary Catheter
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for post-partum depression
The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements
The U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.
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U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond
The President’s 2020 Budget includes new resources to advance the agency’s food safety program, and expand food safety monitoring
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U.S. FOOD AND DRUG ADMINISTRATION: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions
The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.
U.S. FOOD AND DRUG ADMINISTRATION: Gentrix Surgical Matrix Thick
Class 2 Device Recall Gentrix Surgical Matrix Thick
BIOTRONIK: FDA Approves Industry's Smallest, Slimmest 3T Tachycardia Devices from BIOTRONIK
Long-Lasting Devices Feature Unique DX Technology and Enhanced Automation of Heart Failure Therapy
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safety
As FDA finalizes previously proposed extensions to compliance dates for agricultural water requirements, the agency is providing an update on how it is using the additional time to ensure the feasibility of federal requirements and incorporate lessons learned from recent romaine lettuce outbreaks
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves a new generic valsartan
The U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.
U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
U.S. FOOD AND DRUG ADMINISTRATION: Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply
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FDA approves new at home smartphone urinalysis test kit
The FDA recently approved a home urinalysis test kit comparable to clinical testing.
FDA approves new doctor-certified antidepressant nasal spray
The USDA recently approved Spravato (esketamine), a new antidepressant nasal spray.
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon
Advancements in the dynamic field of biotechnology are bringing about the development of innovative, new food products.
U.S. FOOD AND DRUG ADMINISTRATION: Tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan
As the number of children using e-cigarettes remains at epidemic levels, our enforcement work has been one cornerstone of our efforts to protect youth from the dangers of tobacco products.