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
FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

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
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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act
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 (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency ’s ongoing Youth Tobacco Prevention Plan
FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA ’s 510(k) program to advance the review of the safety and effectiveness of medical devices
FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA ’s new plan to advance plant, animal biotechnology innovation
FDA announces new plan to advance the development of plant and animal biotechnology innovation (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes
“Remove the Risk” to raise awareness about proper disposal of prescription opioids (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA approves new drug to treat travelers ’ diarrhea
FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers ’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse
U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency ’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use
Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency ’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

La FDA autoriza la primera prueba de comercializaci ón directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica
La FDA autoriza la primera prueba de comercializaci ón directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

La FDA aprueba nuevo medicamento para tratar la influenza
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA approves first treatment for rare blood disease
The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA approves first treatment for pediatric patients with lupus
FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

FDA approves device to help increase access to more lungs for transplant
The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news

Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply
Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: Food Science Source Type: news

FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes
“Remove the Risk” to raise awareness about proper disposal of prescription opioids (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 25, 2019 Category: American Health Source Type: news

Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API)
Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 25, 2019 Category: Food Science Source Type: news

Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic
This recall has been initiated due to an out of specification result for clarity observed in the stability program. The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel in (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 24, 2019 Category: Food Science Source Type: news

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA ’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA ’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 23, 2019 Category: American Health Source Type: news

Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency ’s new steps to strengthen the process of initiating voluntary recalls
New steps to strengthen the process of initiating voluntary recalls (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 23, 2019 Category: American Health Source Type: news

Statement from Peter Marks, M.D., Ph.D., director of FDA ’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine
The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the U nited States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in th...
Source: Food and Drug Administration - April 22, 2019 Category: American Health Source Type: news

Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling
Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 21, 2019 Category: Food Science Source Type: news

FDA permits marketing of first medical device for treatment of ADHD
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2019 Category: American Health Source Type: news

FDA approves first generic naloxone nasal spray to treat opioid overdose
FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2019 Category: American Health Source Type: news

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2019 Category: Food Science Source Type: news

Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream
Weis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product ’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2019 Category: Food Science Source Type: news

Mondel ē z Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
Mondel ē z Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news

Mondel ēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
Mondel ēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health eff ects have been received. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with < em > Salmonella < /em >
Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: Food Science Source Type: news

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news

Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry ’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint
Unilever is voluntarily recalling a limited quantity of Ben& Jerry ’s Coconut Seven Layer Bar bulk and Ben& Jerry ’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the bac k of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the re...
Source: Food and Drug Administration - April 16, 2019 Category: Food Science Source Type: news

FDA takes action to protect women ’ s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news

FDA takes action to protect women ’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Product Because of Possible Health Risk
Caito Foods is voluntarily recalling fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis because these products have the potential to be contaminated with Salmonella Carrau, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salm...
Source: Food and Drug Administration - April 13, 2019 Category: Food Science Source Type: news

Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility
FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: American Health Source Type: news

FDA approves first targeted therapy for metastatic bladder cancer
The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: American Health Source Type: news

Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk
FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: American Health Source Type: news

SD Import Issues Voluntary Nationwide Recall of Aphrodisiac Capsules Due to Presence of Undeclared Sildenafil
SD Import, LLC is voluntarily recalling all lots of Aphrodisiac, Capsules to the consumer level. The products have been found to be tainted with sildenafil. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient in FDA approved product used in the treatment of erectile dysfunction. The presence of sildenafil in Aphrodisiac capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 12, 2019 Category: Food Science Source Type: news

FDA orders important safety labeling changes for Addyi
FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 11, 2019 Category: American Health Source Type: news

FDA issues final rule on safety and effectiveness of consumer hand sanitizers
FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA ’s OTC Drug Review. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 11, 2019 Category: American Health Source Type: news

Great American Marketing Company Recalls Ready To Eat Products Because of Possible Health Risk
Great American Marketing Company of Houston, Texas is recalling Ready to Eat Sandwiches, Wraps and Salads because they have the potential to be contaminated with LISTERIA MONOCYTOGENES , an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria Infection can cause miscarriages and still births among pregnant women. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 10, 2019 Category: Food Science Source Type: news

Declaraci ón del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de productos legítimos de células madre bajo las reg ulaciones existentes
Declaraci ón de la FDA sobre las acciones de aplicación de las normas sobre células madre y las actividades de la dependencia para facilitar el desarrollo de productos legítimos (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 10, 2019 Category: American Health Source Type: news

Declaraci ó n del comisionado de la FDA sobre los esfuerzos continuos para impedir que las cl í nicas de c é lulas madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de productos leg í timos de c é lulas madre bajo las regulaciones existentes
Declaraci ó n de la FDA sobre las acciones de aplicaci ó n de las normas sobre c é lulas madre y las actividades de la dependencia para facilitar el desarrollo de productos leg í timos (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 10, 2019 Category: American Health Source Type: news

FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
FDA is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 10, 2019 Category: American Health Source Type: news