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By FDAnews
Traditional Approaches for Collaborating with Outsourced Manufacturers and Suppliers Are Failing FDAnews Free Webinar Sponsored by Veeva Systems May 13, 2014 — 1:00 p.m. – 2:00 p.m. EDT www.fdanews.com/SupplyChainCollaborationPR1
By Public Interest Law Professor John Banzhaf
The FDA reported that e-cigarettes pose “acute health risks” which “cannot seriously be questioned” because they contain “toxic chemicals,” and that the devices also “present a serious risk of addicting new users, including children.”
By Professor John Banzhaf, GWU Law School
WASHINGTON, D.C. (April 14, 2014): Leaked documents indicate that electronic cigarettes, also known as e-cigarettes, may be zapped by the World Health Organization [WHO]
By Olympia Pharmacy
Olympia Compounding Pharmacy announced today it has voluntarily registered with the FDA as an outsourcing facility.
By SEMDA
Southeastern Medical Device Association (SEMDA) Addressing Reform Impact Head-on
By Aging in Motion
Experts from the FDA and Science, Industry and Advocacy Groups Discuss Strategies to Advance Treatment for Condition
By GlobalSubmit
Software Release Includes New Module 1 Specifications, Performance Enhancements
By Medicast Inc. And Expect Advertising, Inc.
“Continued use of non-approved drugs when a safe, FDA-approved product is available is not in the public interest and can lead to legal lawsuits.” — Cindy Ippoliti, Pharm.D., NYP/Weill Cornell
By Public Interest Law Professor John Banzhaf
A federal appeals court has ruled that law suits against food companies for misrepresentation are not preempted by federal law, opening the door even further to a growing wave of such suits,
By Public Interest Law Professor John Banzhaf
Many states - just now Missouri - are in danger of having their scheduled executions delayed or even stopped by law suits over the drugs to be injected, but there appears to be a simple remedy which avoids virtually all of the problems
By Immune Response BioPharma Inc.
Immune Response BioPharma, Inc. Announces its Flagship HIV/AIDS Vaccine REMUNE Granted Orphan Designation for Pediatric HIV/AIDS Therapeutic Vaccination by the FDA.
By Farm Plus Financial Farm Loans
According to Farm Plus Financial Farm Loans at http://www.farmloans.com, the Food and Drug Administration recently took the first steps in banning the non-treatment-based use of antibiotics in US livestock, arguing that antibiotic abuse can lead to the...
By FDAnews
Device Supplier Controls: Does the FDA’s Next 483 Have Your Name on It? **FDAnews Virtual Conference** Feb. 26, 2014 — 10:00 a.m. – 4:00 p.m. EST www.fdanews.com/SupplierControlsVCPR1
By Alliance for Natural Health USA
Sammy Hagar, Sen. Kelly Ayotte & 100,000 concerned citizens plead for agency to grant ‘Compassionate Use Exemption’
By Immune Response BioPharma Inc.
Immune Response BioPharma, Inc. Announces its Flagship Vaccine NeuroVax Granted Orphan Designation for Pediatric MS by the FDA.
By The Cornucopia Institute
On December 11, 2013 the U.S. Food & Drug Administration (FDA) released a guidance document that asks animal-drug makers to voluntarily discontinue marketing antibiotics to farmers for faster livestock growth, limiting their use strictly to therapeutic...
By Mary Ann Liebert, Inc., publishers
The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked.
By Immunotech Laboratories Inc.
Immunotech laboratories (immb) is pleased to announce that the financials for auditing have been completed and are now in the process of being audited.
By Professor John Banzhaf, GWU Law School
Nicotine, the substance to which bystanders are exposed when e-cigarettes are used, are a key contributing factor in the almost 50,000 annual nonsmoker deaths from secondhand tobacco smoke - and bystanders deserve to be protected
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.
By FDAnews
Leverage New Tools for Device CAPA Compliance **FDAnews Virtual Conference** Dec. 19, 2013 — 10:00 a.m. – 4:00 p.m.
By FDAnews
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.
By FDAnews
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.
By FDAnews
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
By FDAnews
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
By Groff-Hinman
Recent FDA Approval Spurs Pent-Up Demand Among Middle Aged For New Eyelift Procedure
By FDAnews
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
By FDAnews
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.
By FDAnews
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.
By FDAnews
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
By Labcompliance
This seminar will discuss how to effectively implement GMP regulations in quality control laboratories for FDA and EMA compliance.
By Labcompliance
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
By Labcompliance
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
By FDAnews
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
By RnRMarketResearch.com
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.
By CluePoints
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.
By FDAnews
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.
By ExecutiveGov
ExecutiveGov unveiled a number of timely and important news items this week geared toward the government and government contracting executive.
By FDAnews
Leading the Climb: Seven Essentials of GMP **Presented by LearningPlus and FDAnews** Aug. 19-20, 2013 – Philadelphia, PA www.fdanews.com/LeadingClimbPR1



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