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Newsfeed Results for "FDA"
  • Marginal Zone Lymphona: FDA Approves First Drug For This Rare Form Of Non-Hodgkin's Lymphoma 21 Jan 2017 18:19 GMT Counsel & Heal

    … .S. Food and Drug Administration (FDA) has approved Imbruvica (Ibrutinib) for … .S. Food and Drug Administration (FDA) has approved Imbruvica (Ibrutinib) for … prior anti-CD20-based therapy. "The FDA approval of IMBRUVICA for relapsed … lymphoma, blood cancer, cancer, drug, FDA © 2016 Counsel & Heal All …

  • Skin cancer cream linked to 5 dog deaths:FDA 21 Jan 2017 14:05 GMT KTEN Online

    … pets, said the FDA. "Although the FDA has not to date … euthanized three days later, the FDA said. Cats, usually more finicky … medication when grooming itself, the FDA explained. If you have pets … has used fluorouracil cream, the FDA said. Also, doctors who prescribe …

  • Applied Statistics for FDA Process Validation 21 Jan 2017 13:24 GMT Events & Conferences

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further …

  • FDA announces recall of King's Pastry items sold in Massachusetts 21 Jan 2017 10:59 GMT Cape Cod Today

    King's Pastry, located in Ontario, Canada, is voluntarily recalling the following cakes because the products contained tree nut (hazelnut) allergens that were not listed on the product labels. People who have an allergy or severe sensitivity to tree …

  • Skin Medication Can Be Lethal for Pets, FDA Warns 21 Jan 2017 04:09 GMT Yahoo News

    … , the Food and Drug Administration (FDA) warned today. The agency said … to these animals," the FDA said in a statement. The … Dog Ownership] So far, the FDA has not received any reports … from ingesting the cream, the FDA recommended that owners keep the …

  • FDA commences investigation into fake energy drink 21 Jan 2017 02:13 GMT Ghana News Agency

    … The Food and Drugs Authority (FDA), has commenced investigations into a … Mogtari, Chief Executive Officer of FDA and copied to the Ghana … address the concerns. “Meanwhile, the FDA has taken further steps by … assure the public that the FDA has commenced investigations into the …

  • FDA establishes its Oncology Center of Excellence 21 Jan 2017 00:22 GMT DOTmed.com

    … are being taken as the FDA formalizes the structure and implementation … and Oncology Products in the FDA’s Center for Drug Evaluation … of oncology activities across all FDA Centers and ensured that there was collaboration between the FDA, the National Cancer Institute and …

  • FDA OK’s Amplitute Surgical’s Anatomic Total Knee Prosthesis 21 Jan 2017 00:16 GMT 4-traders

    Amplitude Surgical, based in Valence, France, has received 510(k) approval from the US Food and Drug Administration to market its Anatomic implant that addresses degenerative knee disorders. “Our Anatomic knee has been a real success, with more than 20, …

  • OssDsign wins FDA nod for 3D-printed cranial reconstructive implants 20 Jan 2017 22:55 GMT MassDevice

    … OssDsign said today it won FDA 510(k) clearance for its … , Austria and the Netherlands. “Receiving FDA clearance for our flagship product …

  • Bone Index wins FDA 510(k) for osteoporosis diagnostic device 20 Jan 2017 22:55 GMT MassDevice

    … Index said today it won FDA 510(k) clearance for its … . “The clearance process with the FDA was very fast, only 6 …

  • FDA Seizes Expired Products 20 Jan 2017 22:20 GMT Modern Ghana

    The Food and Drugs Authority (FDA) last December seized about a … through an operation by the FDA to protect the safety of … . The Regional Director of the FDA, Samuel Kwakye, who disclosed this … humans. Mr Kwakye said the FDA was poised to ensure the …

  • Bone Index receives FDA clearance for second generation Bindex point-of-care device for diagnosing osteoporosis 20 Jan 2017 22:01 GMT DOTmed.com

    … the Food and Drug Administration (FDA) for the second generation Bindex … the RadiForce RX850 - the FDA 510 (k) Cleared, ACR Approved … ;The clearance process with the FDA was very fast, only 6 …

  • OssDsign announces FDA clearance of its OSSDSIGN Cranial PSI 20 Jan 2017 22:00 GMT DOTmed.com

    … (k) clearance by the US FDA for marketing and sale of … of OssDsign, said: "Receiving FDA clearance for our flagship product … the RadiForce RX850 - the FDA 510 (k) Cleared, ACR Approved …

  • FDA Mulls Tighter Regulation of Gene-Edited Animals 20 Jan 2017 21:47 GMT Technology Review

    … newly proposed regulations from the FDA may make it harder for … animal drug approval requirements.” The FDA, then, would have to examine … evoke a stronger response. The FDA may be trying to head …

  • Allergan Announces FDA Approval of Rhofade (oxymetazoline hydrochloride) Cream for Facial Erythema Associated with Rosacea 20 Jan 2017 21:40 GMT Pharmaceutical News

    … .S. Food and Drug Administration (FDA) for the topical treatment of … day 29.1 "The FDA approval of Rhofade exemplifies Allergan … with rosacea in adults. The FDA approval of Rhofade represents a … the timing or outcome of FDA approvals or actions, if any …

  • FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation 20 Jan 2017 21:40 GMT Pharmaceutical News

    FDA Approves Trulance (plecanatide) for Chronic … Drug Evaluation III in the FDA’s Center for Drug Evaluation … York-based Synergy Pharmaceuticals Inc. Source: FDA Posted: January 2017 Trulance (plecanatide …

  • FDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS Program 20 Jan 2017 21:40 GMT Pharmaceutical News

    January 18, 2017 -- The FDA has approved the first generic … Evaluation and Mitigation Strategy (REMS). FDA’s approval of generic sodium … generic version of Xyrem, the FDA is maintaining strict safety requirements … medication option for narcolepsy. Source: FDA Posted: January 2017 View comments

  • Rheumatology leaders say FDA biosimilar interchangeability guidance a balanced approach 20 Jan 2017 21:14 GMT Medical Xpress

    … ; "We also applaud the FDA for suggesting clinical studies which … ." Explore further: Rheumatology providers, FDA leaders discuss biosimilars at national … briefing More information: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances …

  • FDA Issues New Seafood Advice For Moms-To-Be 20 Jan 2017 21:04 GMT Indiana Public Media

    … to under-consume seafood. So the FDA issued a new chart explaining … of the Obama Administration, the FDA and Environmental Protection Agency issued … than the new FDA/EPA advisory recommends. The FDA maintains that its … . Agency spokesman Cassell says the FDA believes the recommendations will instill …

  • FDA Announces Draft Guidances on Medical Product Communications 20 Jan 2017 18:13 GMT Packaging World

    … common questions and provides the FDA’s recommendations regarding firms’ communications … With the FDA-Required Labeling,” explains FDA’s current thinking about firms … their products. Related Sponsored Content FDA opened a public comment period … discussion of First Amendment considerations. FDA requests input on the Memorandum …

  • OssDsign Announces FDA 510(k) Clearance of OSSDSIGN® Cranial for Sale in the USA 20 Jan 2017 16:34 GMT MarketWatch.com

    … (k) clearance by the US FDA for marketing and sale of … of OssDsign, said:"Receiving FDA clearance for our flagship product …

  • FDA Issues New Draft Guidance On Medical Product Communications 20 Jan 2017 16:22 GMT AboutLawsuits.com

    … and other promotional materials.  The FDA published the new draft guidance … are drawn regarding what the FDA considers false statements, and how … firms have questions about how FDA determines when communications that contain … such communications are viewed by FDA.” The guidance covers a number …

  • FDA Warns Public About Skin Cancer Creams As It May Kill Pets 20 Jan 2017 16:13 GMT Counsel & Heal

    … ) The Food and Drug Administration (FDA) released a public announcement on … dogs, cats and other animals. FDA received a report were five … owners that use the cream. FDA recommends pet owners to safely … veterinary care. Tagsskin cancer cream, FDA, The Food and Drug Administration …

  • FDA Issues Two Draft Guidances On Medical Product Communications 20 Jan 2017 16:08 GMT Medical Design Online

    … /or reimbursement decisions prior to FDA approval or clearance of investigational … questions and answers on how FDA evaluates firms’ medical product communications … illustrate these concepts," states FDA. The agency is accepting stakeholder … of First Amendment considerations," FDA Commissioner Robert Califf wrote in …

  • Synergy Pharmaceuticals’ TRULANCE(TM) (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation 20 Jan 2017 15:30 GMT salesandmarketingnetwork.com

    … primary endpoint defined by the FDA for regulatory approval in CIC … related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical …