Heartland Institute’s Hudgins says U.S. could learn from Japanese drug-approval model
Heartland Institute’s Hudgins says U.S. could learn from Japanese drug-approval model
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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…
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.
U.S. FOOD AND DRUG ADMINISTRATION: FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall
The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products…
U.S. FOOD AND DRUG ADMINISTRATION: FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight…
U.S. FOOD AND DRUG ADMINISTRATION: LIFEPAK 15 Monitor/Defibrillator service kits recall
Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator
U.S. FOOD AND DRUG ADMINISTRATION: Equinoxe Preserve Humeral Stem, 8mm Recall
Class 2 Device Recall Humeral Stem
U.S. FOOD AND DRUG ADMINISTRATION: The agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse
Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse
U.S. FOOD AND DRUG ADMINISTRATION: FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies
The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force…
U.S. FOOD AND DRUG ADMINISTRATION: FDA’s modern approach to advanced pharmaceutical manufacturing
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing
U.S. FOOD AND DRUG ADMINISTRATION: New strategy to advance FDA’s food safety mission and modernize oversight of imported food
Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer
The U.S. Food and Drug Administration has issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda Hayes, for illegally marketing…
U.S. FOOD AND DRUG ADMINISTRATION: New policy to improve access and foster price competition for drugs that face inadequate generic competition
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition
U.S. FOOD AND DRUG ADMINISTRATION: Cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions
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., cautioning consumers against receiving young donor plasma infusions that…
U.S. FOOD AND DRUG ADMINISTRATION: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
The U.S. Food and Drug Administration permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for…
U.S. FOOD AND DRUG ADMINISTRATION: FDA advances new proposed regulation to make sure that sunscreens are safe and effective
The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants
The U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr.…
U.S. FOOD AND DRUG ADMINISTRATION: FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease
Products make unproven claims for treating multiple diseases and conditions