fda - Latest Newshttp://news.prlog.org/tag/fda/fda - Latest News (Press Releases) - Read news before it's newsen-us3600 Should the FDA Be Doing More to Protect the Public Against Caffeine?http://www.prlog.org/12138222-should-the-fda-be-doing-more-to-protect-the-public-against-caffeine.htmlThe health risks of consuming too much caffeine, especially for vulnerable populations, and the easy availability of these products should cause the U.S. Food and Drug Administration to be especially vigilant and proactive in regulating caffeine. FDA Warns of DMAA Dangers and Bans Distributionhttp://www.prlog.org/12119847-fda-warns-of-dmaa-dangers-and-bans-distribution.htmlEnnis & Ennis, P.A. reports that the FDA is warning of the dangers of DMAA and is working to ensure that any dietary supplements containing the stimulant, dimethylamylamine (DMAA) will no longer be distributed or sold in the U.S. marketplace. Temperature@lert Announces National Natural Products Client Winhttp://www.prlog.org/12116797-temperaturelert-announces-national-natural-products-client-win.html--- Temperature@lert, a leader in environmental condition monitoring, has announced major client win in the natural foods and beverages industry.— Non-Profit Answers Questions About New Drug Aimed At Treating Nausea And Vomiting In Pregnancyhttp://www.prlog.org/12116231-non-profit-answers-questions-about-new-drug-aimed-at-treating-nausea-and-vomiting-in-pregnancy.htmlExperts Say The Drug May Help Curb Some Pregnancy Complications Esmokehub.com Expects a Tough Phase for Major Brands in the Wake of FDA Ban on E Cigaretteshttp://www.prlog.org/12115524-esmokehubcom-expects-tough-phase-for-major-brands-in-the-wake-of-fda-ban-on-cigarettes.htmlMajor e cigarette manufacturing companies are doing everything possible to keep on promoting e cigs as a recreational device and not a smoking cessation device. New White Paper Describes babyLance Safety Heelstick 510(k) Application Processhttp://www.prlog.org/12112563-new-white-paper-describes-babylance-safety-heelstick-510k-application-process.htmlExamines Additional Considerations for Sharps Prevention Features and Submissions for a Modified Medical Device with Existing 510(k)... New Report: E-Cigarette Vapors Have High Concentrations of Metalshttp://www.prlog.org/12110404-new-report-cigarette-vapors-have-high-concentrations-of-metals.htmlAs the FDA is poised to issue new rules governing e-cigarettes, a new study has found some 22 potentially dangerous chemical elements in the vapor given off or inhaled - Other studies also find risks, and major health organizations warn... Evolution of healthcare products in Mumbai - rablonhealthcare.comhttp://www.prlog.org/12096894-evolution-of-healthcare-products-in-mumbai-rablonhealthcarecom.htmlMumbai (http://www.rablonhealthcare.com/): Mumbai has gained enough popularity as being the popular industrial city, moreover, being the initiative city that provides employment to so many people. Contract manufacturing supported by Rablon - rablonhealthcare.comhttp://www.prlog.org/12095384-contract-manufacturing-supported-by-rablon-rablonhealthcarecom.htmlRablon healthcare Pvt Ltd this company made its presence in the pharmaceutical market in the year 2012 & from then has been employing effective techniques to mark a positive impression in the minds of the people. "Local Pilot Fights Rare Disease Online"http://www.prlog.org/12094979-local-pilot-fights-rare-disease-online.htmlAfter 14 years as a pilot for a corporate airline, the FDA grounded A.J. Catone when he was diagnosed with a rare disease, neuroendocrine tumor cancer which became infamous when Steve Jobs of Apple succumbed to it in 2011. GPMG Unveils a Quality System Product Designed for Initial Importers of Medical Deviceshttp://www.prlog.org/12087042-gpmg-unveils-quality-system-product-designed-for-initial-importers-of-medical-devices.htmlGPMG, a medical device consulting firm, unveiled a new product to help Initial Importers of medical devices comply with FDA regulations. The design of the system allows for immediate implementation and fits varying organizational structures. Labeling Considerations in the European Union and its Impact on Global Labeling Compliancehttp://www.prlog.org/12084796-labeling-considerations-in-the-european-union-and-its-impact-on-global-labeling-compliance.htmlInterview with Mary Elicone, Associate Director, Global Regulatory Affairs Labeling at Sanofi US MediPurpose Receives U.S. FDA 510(k) Clearance for Redesigned babyLance Safety Heelstickhttp://www.prlog.org/12083291-medipurpose-receives-us-fda-510k-clearance-for-redesigned-babylance-safety-heelstick.htmlOnly Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication Implementation Progress of the US Food Safety Modernization Acthttp://www.prlog.org/12080593-implementation-progress-of-the-us-food-safety-modernization-act.html2012 was to be a busy and significant year for the US Food Safety Modernisation Act. The last 12 months have seen the majority of its programmes drafted, but because of government review procedures no major programme has been implemented yet. World's First FDA Cleared ALK Automated Gene Scannerhttp://www.prlog.org/12079826-worlds-first-fda-cleared-alk-automated-gene-scanner.htmlWorld's First FDA Cleared ALK Automated Gene Scanner for Lung Cancer Therapy-Selection Available from ASI Targeting the Right Treatment for the Right Patient in ALK Therapy Selection for Non-Small-Cell Lung Cancer FDA Issues Safety Communication Regarding Metal-On-Metal Hipshttp://www.prlog.org/12075613-fda-issues-safety-communication-regarding-metal-on-metal-hips.htmlThe Food and Drug Administration (FDA) issued a Safety Communication on January 17, 2013 to the medical community and patients who are considering or have received a metal-on-metal hip implant, warning of the unique risks of all-metal implants. Is Your Doctor Pulling a Botox Bait and Switch?http://www.prlog.org/12051971-is-your-doctor-pulling-botox-bait-and-switch.htmlFDA alerts more than 350 medical practices nationwide that they may have purchased unapproved Botox. Are these practices risking your health to save a few bucks? Dynamic faculty to focus on conducting clinical trials in Latin America at ACI's Pharma Latam Forumhttp://www.prlog.org/12049271-dynamic-faculty-to-focus-on-conducting-clinical-trials-in-latin-america-at-acis-pharma-latam-forum.htmlTake this opportunity to benchmark your internal protocols against those of you peers at Allergan, AstraZeneca, Bayer, BioMarin Pharmaceuticals Inc., Bristol Myers, GlaxoSmithKline, Grünenthal, J&J, Merck, Inc., Pfizer, Roche, Teva and more Barbara Kopple’s New Documentary Fight to Live at DOC NYC Film Festivalhttp://www.prlog.org/12019467-barbara-kopples-new-documentary-fight-to-live-at-doc-nyc-film-festival.htmlTwo time Oscar winner Barbara Kopple (Harlan Country USA, American Dream) explores in her new documentary Fight to Live the absolute powers of the FDA over our rights and access to therapies needed to fight deadly diseases. The New TECHLAB® Shiga Toxin E. coli Rapid Test Receives FDA Clearancehttp://www.prlog.org/12012001-the-new-techlab-shiga-toxin-coli-rapid-test-receives-fda-clearance.htmlAlere Inc. received confirmation that the U.S. Food and Drug Administration (FDA) has cleared the TECHLAB® SHIGA TOXIN QUIK CHEK test for the U.S. market. ZI XIU TANG Bee Pollen Capsules banned by FDAhttp://www.prlog.org/12008718-zi-xiu-tang-bee-pollen-capsules-banned-by-fda.htmlThe FDA released a stop selling and stop using order yesterday to any sellers, distributors, or users of Zi Xiu Tang bee pollen capsules. Leading Seniors Website Publisher Urges FDA Extend ‘Reciprocity’ To Personal Importationhttp://www.prlog.org/11994978-leading-seniors-website-publisher-urges-fda-extend-reciprocity-to-personal-importation.htmlDaniel Hines, publisher of TodaysSeniorsNetwork.com, warns of unintended consequences of FDA misidentifying safe internet pharmacies, urges extension of reciprocity to personal importation of safe, affordable prescription medicines. System Based Inspections - Laboratory Controlshttp://www.prlog.org/11990012-system-based-inspections-laboratory-controls.htmlThis 90-minute training on the FDA system based inspection technique will focus on the responsibilities of the laboratory within the systems based inspection approach and will help the personnel in the quality control laboratory. New Edition on the Reliable Design of Medical Devices Now Available from CRC Presshttp://www.prlog.org/11986014-new-edition-on-the-reliable-design-of-medical-devices-now-available-from-crc-press.htmlFollowing in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Updatehttp://www.prlog.org/11987973-us-food-and-drug-administration-fda-food-safety-modernization-act-fsma-update.htmlPending Changes To FDA Food Facility Registrations and Reregistrations Web Seminar: FDA Compliant IT Infrastructure and Network Qualificationhttp://www.prlog.org/11979988-web-seminar-fda-compliant-it-infrastructure-and-network-qualification.htmlThis web-seminar will discuss requirements and strategies for cost-effective qualification of IT Infrastructure and Network in FDA regulated and international environments. Attendes will receive 10+ best practice guides for easy implementation. Web Seminar: Validation and Use of Cloud Computing in FDA Regulated Environmentshttp://www.prlog.org/11979829-web-seminar-validation-and-use-of-cloud-computing-in-fda-regulated-environments.htmlThis web seminar will discuss how to how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies. Attendes will receive 10+ best practice guides for easy implementation. Web Seminar: Validation of Analytical Methods for GLP and Clinical Studieshttp://www.prlog.org/11979794-web-seminar-validation-of-analytical-methods-for-glp-and-clinical-studies.htmlThis web-seminar will discuss how to design, prepare, conduct and document method validation exaperiments for Good Laboratory Practice and Good Clinical Practice studies. Attendes will receive 10+ best practice guides for easy implementation. Web Seminar: Using Electronic Signatures in FDA and EMA Regulated Environmentshttp://www.prlog.org/11976255-web-seminar-using-electronic-signatures-in-fda-and-ema-regulated-environments.htmlThis web-seminar will discuss how to use electronic and digital signatures for FDA and international compliance. ACI's Hatch-Waxman series: The 13th edition of Maximizing Pharmaceutical Patent Life Cycleshttp://www.prlog.org/11974389-acis-hatch-waxman-series-the-13th-edition-of-maximizing-pharmaceutical-patent-life-cycles.htmlOn October 10th, ACI will kickoff this season’s Hatch-Waxman series with the 13th edition of Maximizing Pharmaceutical Patent Life Cycles at the Downtown Marriott Hotel in New York City. ACI’s Forum on Orphan Drugs Boasts a “Who’s Who” of FDA Regulatoryhttp://www.prlog.org/11972354-acis-forum-on-orphan-drugs-boasts-whos-who-of-fda-regulatory.htmlACI introduces its Guide to Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process. Laboratory Equipment Qualification according to USP 1058http://www.prlog.org/11962854-laboratory-equipment-qualification-according-to-usp-1058.htmlThis seminar will discuss how to apply USP chapter for all laboratory equipment and systems Are There Gender Differences in Anti-HIV Drug Efficacy?http://www.prlog.org/11946031-are-there-gender-differences-in-anti-hiv-drug-efficacy.htmlThe U.S. Food and Drug Administration (FDA) has created a database from 40 clinical studies to assess gender differences in the efficacy of antiretroviral treatments. The results of the study are presented in an article in AIDS Patient Care and STDs. Ganeden Biotech® Receives FDA Generally Recognized As Safe (GRAS) Status for GanedenBC30®http://www.prlog.org/11940551-ganeden-biotech-receives-fda-generally-recognized-as-safe-gras-status-for-ganedenbc30.htmlGaneden Biotech Receives “No Objection” Letter from the FDA; GanedenBC30 is First Bacillus Strain to Receive GRAS Status Four FDA Thought-Leaders to Present at CHI’s Immunogenicity Summit 2012http://www.prlog.org/11939736-four-fda-thought-leaders-to-present-at-chis-immunogenicity-summit-2012.htmlWith representation by Susan Kirshner, Jack Ragheb, Amy Rosenberg, and Daniela Verthelyi. Verification of Compendial Methods according to the Revised USP Chapter 1226http://www.prlog.org/11937171-verification-of-compendial-methods-according-to-the-revised-usp-chapter-1226.htmlThis seminar will discuss the new risk based approach and attendees will get get real world case studies for testing BPA Is Banned from Baby Bottles and Sippy Cups by the FDAhttp://www.prlog.org/11929277-bpa-is-banned-from-baby-bottles-and-sippy-cups-by-the-fda.htmlEMSL Analytical provides testing for BPA in consumer products, in food samples, and in the air for workplace exposure assessments. FDA GMP QSR Hands On Workshop in Miami August 2, 2012 - Lean Compliance Partnershttp://www.prlog.org/11924480-fda-gmp-qsr-hands-on-workshop-in-miami-august-2-2012-lean-compliance-partners.htmlLearn about FDA QSR, cGMP, GMP. How FDA guidelines apply to medical device manufacturing and product quality. Identify gaps in the quality system. Immediately apply learnings in your workplace. Hands on, live instructor training in Miami / Doral. Gain a comprehensive overview of regulatory requirements for food and beverage products athttp://www.prlog.org/11920862-gain-comprehensive-overview-of-regulatory-requirements-for-food-and-beverage-products-at.htmlACI’s FDA & USDA Compliance Boot Camp will engage attendees in a deep-dive, two-day examination of food law fundamentals, including an intense exploration of regulations governing food, including meat, poultry and egg products, as well as beverages CME Coalition Applauds FDA approval of REMS for ER/LA Opioid Analgesicshttp://www.prlog.org/11919680-cme-coalition-applauds-fda-approval-of-rems-for-erla-opioid-analgesics.htmlFDA highlights the vital role of CME in educating physicians and improving patient outcomes. Achieving Quality and Compliance Excellence in Pharmaceuticals - New Book Releasedhttp://www.prlog.org/11915837-achieving-quality-and-compliance-excellence-in-pharmaceuticals-new-book-released.htmlThis latest book released by Business Horizons represents the latest global quality standards that pharmaceutical manufacturers are striving for today, in order to achieve compliance in today's stringent norms by regulatory agencies. Comprehensive Food Law Refresher Course - ACI's FDA & USDA Compliance Boot Camphttp://www.prlog.org/11908565-comprehensive-food-law-refresher-course-acis-fda-usda-compliance-boot-camp.htmlACI is pleased to announce its upcoming, FDA & USDA Compliance Boot Camp, scheduled to take place on October 3-4, 2012 at the Millennium Knickerbocker in Chicago, IL. IPA Excited To Learn The FDA Has Decided To Issue A New, Revised NDI Draft Guidancehttp://www.prlog.org/11905372-ipa-excited-to-learn-the-fda-has-decided-to-issue-new-revised-ndi-draft-guidance.htmlInternational Probiotics Association looking forward to working with FDA to develop proper guidance necessary to deliver safe and effective supplements to consumers Tim Forrest presented in Germany at Food Forum USA June 15.http://www.prlog.org/11902520-tim-forrest-presented-in-germany-at-food-forum-usa-june-15.htmlHANNOVER, Germany, June 15 , 2012 — Tim Forrest Consulting (St. Simons Island, Georgia), a recognized food industry leader, presented on FDA regulations, US distribution channels, and product marketing to 58 companies on June 14 at Food Forum USA. “Food Forum USA” & “Fit for FDA” to be held at the Hanover Chamber of Industry and Commercehttp://www.prlog.org/11899915-food-forum-usa-fit-for-fda-to-be-held-at-the-hanover-chamber-of-industry-and-commerce.htmlFDA regulations, distribution channels, product marketing, the U.S. organics market and risk management are among the topics to be discussed at upcoming events in Hanover. CHI Releases Final Agenda for the 4th Annual Immunogenicity Summit 2012http://www.prlog.org/11898044-chi-releases-final-agenda-for-the-4th-annual-immunogenicity-summit-2012.htmlWorld Leaders to Convene on October 10-12, 2012, Bethesda, MD CHI's Regulatory Compliance in Drug-Diagnostics Co-Development Conference, August 21-22, 2012, DChttp://www.prlog.org/11874668-chis-regulatory-compliance-in-drug-diagnostics-co-development-conference-august-21-22-2012-dc.htmlThis conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic (August 21-23). Hoag Doctors’ Report Contributes to FDA Action Regarding Unproven MS Treatmenthttp://www.prlog.org/11873060-hoag-doctors-report-contributes-to-fda-action-regarding-unproven-ms-treatment.htmlHoag Memorial Hospital Presbyterian Doctor publishes article alerting people with MS about serious negative effects of Liberation Therapy CHI to Hold its 2nd Mass Spectrometry in Clinical Diagnostics Conference, August 21-22, 2012, DChttp://www.prlog.org/11872764-chi-to-hold-its-2nd-mass-spectrometry-in-clinical-diagnostics-conference-august-21-22-2012-dc.htmlThis conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic (Aug. 21-23). CHI to Host the 3rd Annual Companion Diagnostics Conference, Aug. 22-23, 2012, Washington, DChttp://www.prlog.org/11870521-chi-to-host-the-3rd-annual-companion-diagnostics-conference-aug-22-23-2012-washington-dc.htmlHear Diagnostics Perspectives on Personalized Medicine and Companion Tests. This conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic.