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By Immune Response BioPharma
Immune Response BioPharma, Inc., Announces its Plans to Develop Annual Preventative HIV/AIDS Vaccine RemuneVax IR-2020 Based on Current Mutated HIV Strain for Preventative Use.
By Public Interest Law Professor John Banzhaf
Simple Regulations Cost Nothing, and Are Much More Efficient
By Better Shea Butter
Better Shea Butter has recently launched a new zinc oxide powder that offers customers excellent value for money.
Leverage New Tools for Device CAPA Compliance **FDAnews Virtual Conference** Dec. 19, 2013 — 10:00 a.m. – 4:00 p.m.
By Immune Response BioPharma
Immune Response BioPharma to File Remune BLA with FDA by March 1st 2014 & Submits Fee Waiver Request, IRBP also plans to Transition the Vaccine to Preventative Use.
By Immune Response BioPharma, Inc.
Immune Response BioPharma to Keep U.S. NeuroVax Rights for MS Expects Phase IIb Enrollment to Begin by Q2 2015.
Ensuring Market Success Via Environmental Compliance: How RoHS and REACH Could Hamper Your EU Sales **FDAnews FREE Webinar** Nov. 20, 2013 — 1:30 p.m. – 3:00 p.m. EST www.fdanews.com/MarketSuccessPR1
By A.D. Allen
Research scientist publishes a review of a public health crisis in online journal ADVANCES IN AGING RESEARCH.
The FDA Unique Device Identification (UDI) Rule It’s Ready for You, Are You Ready for It? **FDAnews Virtual Conference** Nov. 19, 2013 — 10:00 a.m. – 4:00 p.m. EST www.fdanews.com/UDIVirtualPR1
By SMi Group
SMi is delighted to announce that the former MHRA GMP Inspector, Di Morris, who is now consulting for Pharmaceutical Solutions Ltd, will be making a keynote address at SMi’s 3rd annual conference on Pharmaceutical Microbiology.
By Kemwell Biopharma
Cirrus Pharmaceuticals, Inc., NC, USA, a wholly owned subsidiary of Kemwell Biopharma Pvt. Ltd., announced that it was awarded a grant by the U.S.
Medical Device Risk Management Beyond FMEA —New Tools to Assure Your Risk Management Program Meets New Standards **Presented by Ombu Enterprises and FDAnews** Nov. 5-6, 2013 — Chicago, IL www.fdanews.com/MDRiskPR1
Cybersecurity Threats to Medical Devices Crush the Hackers Before They Crush You **FDAnews Webinar** Oct. 18, 2013 — 1:30 p.m. – 3:00 p.m. EDT www.fdanews.com/CybersecurityPR1
Recent FDA Approval Spurs Pent-Up Demand Among Middle Aged For New Eyelift Procedure
Pay-to-Delay Settlements in the Wake of Activis Current, Former FTC Officials Offer Answers **FDAnews Virtual Conference** Oct. 15, 2013 — 10:00 a.m. – 12:30 p.m. EDT www.fdanews.com/PayToDelayPR1
Is it an application or a device? The FDA breaks new ground.
By Mary Ann Liebert, Inc., publishers
Regulatory reform is needed to protect consumers from caffeine-induced harm and to help them make wise dietary choices, say the authors of an article in Journal of Caffeine Research.
Eighth Annual FDA Inspections Summit New Powers, New Enforcement Posture, New Challenges **Presented by FDAnews** Oct. 23-25, 2013 – Bethesda, MD www.fdanews.com/FDAInspectionsSummitPR1
By smi group
Diabetes drug sales soared to a worldwide value of $34.1 billion in 2012, a compound annual growth rate of 10% since 2007.
FDA Import Holds New Powers to Control Products **FDAnews Virtual Conference** Sept. 24, 2013 — 10:00 a.m. – 4:00 p.m. EDT www.fdanews.com/ImportHoldsVCPR1
This seminar will discuss how to effectively implement GMP regulations in quality control laboratories for FDA and EMA compliance.
This seminar will discuss how to use modern lifecycle management and quality by design principles to ensure method robustness for easy transfer and to avoid OOS situations
This seminar will give an overview on ICH Q3D and USP approaches to specify and control elemental impurities to below toxic limits in drug products and ingredients. The seminar will discuss in detail selected elements, limits and analytical procedure
Eighth Annual FDA Inspections Summit New Powers, New Enforcement Posture, New Challenges **Presented by FDAnews** Oct. 23-25, 2013 – Bethesda, MD www.fdanews.com/FDAInspectionsPR1
RnR Market Research adds new report on “PharmaFocus Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria” in its database.
By Ephedra Warehouse
Safety First – Beta Labs Reformulates Products for Consumers Las Vegas, NV — Safety comes first at Beta Labs, Ltd. This supplement company strives to deliver high quality weight loss products to its consumers. Products from Beta Labs, Ltd.
CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that its CSM techniques, that have been developed to improve data quality in studies, have been cited by the FDA in the recent release.
Is It a Cosmetic, a Drug or Both? 15-Year Regulatory Veteran Shares Compliance Secrets **Presented by FDAnews** Aug. 23, 2013 • 1:30 p.m. – 3:00 p.m.
By Chiral Quest
First USDMF Filed by Chiral Quest. Suzhou, Jiangsu, PR China. April 15th, 2013.
By Lean Compliance Partners LLC
Learn about FDA QSR, cGMP, GMP. Learn how FDA guidelines apply to medical device manufacturing and product quality. Identify gaps in quality system. Immediately apply learnings in your workplace. Hand on, live instructor training.
By Conversational Content, LLC
Healthy Food and Lifestyle Brand Applauds the Clear Guidelines
By James Roe, Pharmacist
On Monday, July 29, 2013 at 3 pm EST, James Roe the owner and Pharmacist at Market Place Pharmacy would love to share with his listenrs about what the pharmacy offers and what services they provide for the clientele and the community.
ExecutiveGov unveiled a number of timely and important news items this week geared toward the government and government contracting executive.
Leading the Climb: Seven Essentials of GMP **Presented by LearningPlus and FDAnews** Aug. 19-20, 2013 – Philadelphia, PA www.fdanews.com/LeadingClimbPR1
By Three Square Market
July 18, 2013 – Hudson, Wisc. – Projections of final action move from April to September 2013 for the Food and Drug Administration’s (FDA) calorie disclosure rules still leave many vending machine operators wondering what’s next.
By Compliance Trainings
Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT Duration : 60 Minutes
This web-seminar will discuss how to set parameters and acceotance limits for system suitability testing of chromatographic and other methods
This web-seminar is designed as introductory training on GMPs for new employees and as refresher and update training for everybody working in FDA GMP and equivalent international environments
This seminar will discuss how to manage Out-of-Trend (OOT) results for FDA compliance.
This web-seminar will discuss how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies.
By American Conference Institute
American Conference Institute (ACI) is pleased to announce that Daniel Fabricant, Director of the FDA's Division of Dietary Supplement Programs at the Office of Nutrition, Labeling and Dietary Supplements and Scott Bass, head of Sidley Austin's Global...
This training on FDA cGMPs for Dietary Supplements and Nutraceuticals will discuss current FDA regulations, GMP requirements and techniques to be compliant using easier, shorter and convenient strategies.
By Mary Ann Liebert, Inc., publishers
The 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.
By Ennis & Ennis, P.A.
Ennis & 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.
By New American Nutrition
Author and Primal lifestyle expert, Gary Collins, agrees with FDA’s latest consumer warning about DMAA-containing supplements and offers a safe, natural alternative for a pre-workout boost.
--- Temperature@lert, a leader in environmental condition monitoring, has announced major client win in the natural foods and beverages industry.—
By Organization of Teratology Information Specialists
Experts Say The Drug May Help Curb Some Pregnancy Complications
Examines Additional Considerations for Sharps Prevention Features and Submissions for a Modified Medical Device with Existing 510(k)...
By Professor John Banzhaf, GWU Law School
As 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...
By Rablon Healthcare Pvt Ltd
Mumbai (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.
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