FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.
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FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake
Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.
FDA approves new DNA-based test to determine blood compatibility
FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results
Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.
Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.
Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen
Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.
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Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination
Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.
Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk
BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.
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Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk
Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems