Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles - FDA Safety Alerts & Drug Recalls

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

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Quality Payment Program Exceeds Year 1 Participation Goal - CMS Blog

By: Administrator, Seema Verma, Centers for Medicare & Medicaid Services

Quality Payment Program Exceeds Year 1 Participation Goal 

I’m pleased to announce that 91 percent of all clinicians eligible for the Merit-based Incentive Payment System (MIPS) participated in the first year of the Quality Payment Program (QPP) – exceeding our goal of 90 percent participation. Remarkably, the submission rates for Accountable Care Organizations and clinicians in rural practices were at 98 percent and 94 percent, respectively. What makes these numbers most exciting is the concerted efforts by clinicians, professional associations, and many others to ensure high quality care and improved outcomes for patients.

Meeting the Challenges Ahead

Even with this high rate of participation, we are committed to removing more of the regulatory burdens that get in the way of doctors and other clinicians spending time with their patients. After only eight months, we’ve made significant progress through our Patients over Paperwork initiative: streamlining our regulations, increasing efficiencies, and improving care for patients. At the same time, we continue to put patients first by protecting the safety of our beneficiaries and strengthening the quality of healthcare they receive.

For example, we reviewed many of the MIPS requirements and developed policies for 2018 that continue to reduce burden, add flexibility, and help clinicians spend less time on unnecessary requirements and more time with patients.

In particular we have:

• Reduced the number of clinicians that are required to participate giving them more time with their patients, not computers.
• Added new bonus points for clinicians who are in small practices, treat complex patients, or use 2015 Edition Certified Electronic Health Record Technology (CEHRT) exclusively as a means of promoting the interoperability of health information.
• Increased the opportunity for clinicians to earn a positive payment adjustment.
• Continued offering free technical assistance to clinicians in the program.

Under the Bipartisan Budget Act of 2018 we have additional authority to continue our gradual implementation of certain requirements for three more years to further reduce burden in areas of MIPS.

We’re also eager to improve the clinician and patient experience through our Meaningful Measures initiative so that clinicians can spend more time providing care to their patients and improving the quality of care their patients receive. Within MIPS, we are adopting measures that improve patient outcomes and promote high-quality care, instead of focusing on processes.

Working with the Healthcare Community

We want to express our gratitude to all of the clinicians who collaborated with us as part of the voluntary Clinician Champions Program and the Clinician Voices initiative. We also want to thank all of you who participated in our various listening sessions and user groups throughout the year. Your input and feedback opened a dialogue, highlighted opportunities for improvement, and helped us identify ways to continue to reduce burden within the Quality Payment Program.

We deeply appreciate the contributions professional associations, consumer advocates and other important stakeholders have made to help engage their members and prepare them for success. We also want to acknowledge the networks supporting the free technical assistance available to clinicians, specifically the Small, Underserved, and Rural Support initiative, Quality Innovation Networks, and the Transforming Clinical Practice Initiative, who worked tirelessly to help clinicians familiarize themselves with the program so they can successfully participate. Together with our stakeholders and technical assistance networks, we hosted over 6,000 Quality Payment Program events last year. We used these events to describe requirements, offer tips, listen to you, and act on your feedback.

And, we’re proud to announce that our free technical assistance received a 99.8 percent customer satisfaction rating by over 200,000 clinicians and practice managers. The technical assistance networks also responded to 98.7 percent of initial referrals for additional support from the Quality Payment Program Service Center and Centers for Medicare & Medicaid Services (CMS) Regional Offices within 1-business day. We believe that there is an obligation to respond quickly, so clinicians can spend less time trying to figure out the program and more time with their patients.

Additionally, our Quality Payment Program Service Center complemented the technical assistance effort by fielding more than 130,000 inquiries and delivering world class customer support.

Better yet, all of the free and customized support from the technical assistance networks and the Quality Payment Program is still available to clinicians in the 2018 performance year!

Moving Forward Together

While we’re proud of what has been accomplished, there is more work to be done. CMS remains committed to listening to the healthcare community and exploring ways to reduce clinician burden, strengthen quality, introduce new payment models, develop meaningful measures including for patient safety, and promote interoperability. We look forward to continuing to hearing from you to make sure that we focus on patients, not paperwork.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access - FDA Press Releases

FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry

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H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets recalled for broken metal in processing equipment - FDA Safety Alerts & Drug Recalls

Committed to the quality of its products, H-E-B is voluntarily issuing an all-store recall for certain flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets for broken metal in processing equipment found during routine maintenance. The affected products were distributed to stores in Texas and Mexico.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act - FDA Press Releases

FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients

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FDA approves new treatment for moderately to severely active ulcerative colitis - FDA Press Releases

FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

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As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion - FDA Press Releases

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

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Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules - FDA Safety Alerts & Drug Recalls

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.

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Pious Lion Voluntary Recall Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is 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, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

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Activity of DNA-targeted C8-linked pyrrolobenzodiazepine–heterocyclic polyamide conjugates against aerobically and hypoxically grown Mycobacterium tuberculosis under acidic and neutral conditions - Journal of Antibiotics

Activity of DNA-targeted C8-linked pyrrolobenzodiazepine–heterocyclic polyamide conjugates against aerobically and hypoxically grown Mycobacterium tuberculosis under acidic and neutral conditions

Activity of DNA-targeted C8-linked pyrrolobenzodiazepine–heterocyclic polyamide conjugates against aerobically and hypoxically grown <i>Mycobacterium tuberculosis</i> under acidic and neutral conditions, Published online: 24 May 2018; doi:10.1038/s41429-018-0068-5

Activity of DNA-targeted C8-linked pyrrolobenzodiazepine–heterocyclic polyamide conjugates against aerobically and hypoxically grown Mycobacterium tuberculosis under acidic and neutral conditions

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FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit - FDA Press Releases

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

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Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has the potential to be contaminated with Salmonella, 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 Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens - FDA Press Releases

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

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FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses - FDA Press Releases

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

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Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor - FDA Safety Alerts & Drug Recalls

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies - FDA Safety Alerts & Drug Recalls

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure - FDA Press Releases

FDA approves Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure.

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Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, 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, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

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MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls - FDA Safety Alerts & Drug Recalls

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

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FDA approves novel preventive treatment for migraine - FDA Press Releases

FDA approves Aimovig for the preventive treatment of migraine. Aimovig works by blocking the activity of a molecule that is involved in migraine attacks.

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BLM Issues Allergy Alert On Undeclared Egg and Milk - FDA Safety Alerts & Drug Recalls

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

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New antioxidants from the culture broth of Hericium coralloides - Journal of Antibiotics

New antioxidants from the culture broth of Hericium coralloides

New antioxidants from the culture broth of <i>Hericium coralloides</i>, Published online: 17 May 2018; doi:10.1038/s41429-018-0067-6

New antioxidants from the culture broth of Hericium coralloides

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FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products - FDA Press Releases

FDA continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette makers requiring them to submit important documents to better understand the youth appeal.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition - FDA Press Releases

FDA statement on certain tactics drug makers may be pursuing to delay generic competition

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FDA approves first epoetin alfa biosimilar for the treatment of anemia - FDA Press Releases

FDA approves Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia

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FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients - FDA Press Releases

FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices

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FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan - FDA Press Releases

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

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FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement) - FDA Safety Alerts & Drug Recalls

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product - FDA Safety Alerts & Drug Recalls

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Ampicillin and Sulbactam For Injection USP 3 Grams Due to The Presence of Visible Particulate Matter - FDA Safety Alerts & Drug Recalls

AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams*/ Single-Dose vial, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.

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FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding - FDA Press Releases

FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling

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Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

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FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer - FDA Press Releases

FDA approves Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer

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Voluntary Recall of Certain Golden Flake, Good Health, UTZ and Weis Brand Tortilla Chips Because of Possible Milk Allergen - FDA Safety Alerts & Drug Recalls

Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies - FDA Press Releases

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

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Antibacterial anthraquinone derivatives isolated from a mangrove-derived endophytic fungus Aspergillus nidulans by ethanol stress strategy - Journal of Antibiotics

Antibacterial anthraquinone derivatives isolated from a mangrove-derived endophytic fungus Aspergillus nidulans by ethanol stress strategy

Antibacterial anthraquinone derivatives isolated from a mangrove-derived endophytic fungus <i>Aspergillus nidulans</i> by ethanol stress strategy, Published online: 01 May 2018; doi:10.1038/s41429-018-0063-x

Antibacterial anthraquinone derivatives isolated from a mangrove-derived endophytic fungus Aspergillus nidulans by ethanol stress strategy

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Anti-Rhizopus activity of tanzawaic acids produced by the hot spring-derived fungus Penicillium sp. BF-0005 - Journal of Antibiotics

Anti-Rhizopus activity of tanzawaic acids produced by the hot spring-derived fungus Penicillium sp. BF-0005

Anti-<i>Rhizopus</i> activity of tanzawaic acids produced by the hot spring-derived fungus <i>Penicillium</i> sp. BF-0005, Published online: 01 May 2018; doi:10.1038/s41429-018-0049-8

Anti-Rhizopus activity of tanzawaic acids produced by the hot spring-derived fungus Penicillium sp. BF-0005

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