Category: News

Rx-360 Announces Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for May: Christian Liebl, Innovations and Process Manager [...]
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DEA’s National Take Back Day – April 27th 2019 @ 10:00am
The National Prescription Drug Take Back Day addresses a crucial public safety and public health issue. According to the 2017 National [...]
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FDA: Safe Opioid Disposal – Remove the Risk Outreach Toolkit
Remove the Risk raises awareness of the serious dangers of keeping unused opioid pain medicines in the home and provides information [...]
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SINGLE USE SYSTEMS – AUDITS AVAILABLE FOR LICENSING
SINGLE USE SYSTEMS – AUDITS AVAILABLE FOR LICENSING The below audits have been conducted at the listed sites and are [...]
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Rx-360 Announces Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for March: Christopher Brown, Manager, GMP/GDP Audits Global [...]
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Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan…
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due [...]
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FDA Warns CanaRx for Selling Unapproved, Misbranded and Unsafe Imported Drugs to Unsuspecting Americans
The U.S. Food and Drug Administration posted a warning letter to CanaRx for facilitating the distribution of unapproved new drugs and [...]
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Memorandum on Combating Trafficking in Counterfeit and Pirated Goods
Issued on: April 3, 2019 President Donald J. Trump issued a memorandum on Combating Trafficking in Counterfeit and Pirated Goods. [...]
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Rx-360 Supplier Led Working Group Releases Pre-Audit Questionnaire
The Rx-360 Supplier Lead Working Group is pleased to announce the release of the newest module for the Supplier Assessment [...]
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Rx-360 BPOG Collaboration – Single Use Systems; Audits Now Available for Licensing
Rx-360 in conjunction with the BioPhorum Group have identified the current value of joint audits throughout the industry.  The purpose [...]
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Fraudulent Correspondence – Warning to all Members & Non-Members
Dear Rx-360 Members & Non-Members, Rx-360 has been made aware that fraudulent correspondence was sent to a small number of [...]
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Rx-360 Announces Sponsorship Opportunities for 10 Year Anniversary Celebration!
Rx-360 is pleased to share the sponsorship opportunities for our 10 Year Anniversary Celebration!!   Click Here to View Sponsorship [...]
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Rx-360 Announces Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for January: Leo Vaytsman, Regional Manager of Global [...]
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SAVE THE DATE: Rx-360 Announces 10 Year Anniversary Banquet!!
10 Year Anniversary Save the Date (Click Here) Come help us celebrate our 10 Year Anniversary!! When: Wednesday, September 18 Cocktail [...]
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Rx-360 Announces Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for December: Cheryl Basile, Manager, QA GMP Planning [...]
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Rx-360 Announces Move to Philadelphia, PA
Rx-360 is very excited to announce they are moving their main office to Philadelphia, Pennsylvania.  This move will be effective March 1, [...]
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FDA Says Up to Two Million People Exposed to Likely Carcinogens in Blood-Pressure Drugs
As many as two million people world-wide have been exposed to a class of generic blood-pressure drugs containing probable human [...]
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2019: Moving the Needle in Supply Chain Security and Patient Safety
To:         All Rx-360 Members From:    Jim Fries Re:         2019:  Moving the Needle in Supply Chain Security and Patient [...]
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Revisoin 7 of ICH Q3C Guideline for Residual Solvents
In October 2018, the ICH Management committee issued Revisoin 7 of ICH Q3C Guideline for Residual Solvents.  The only change [...]
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Five additional countries to benefit from EU-US mutual recognition agreement for inspections | European Medicines…
The US FDA has completed the capability assessment for an additional 5 EU regulators in November 2018: Estonia (State Agency [...]
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Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality…
Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and [...]
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FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou [...]
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Rx-360 Announces Scott Kammer as Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for November: Scott Kammer, Director, Global Product Protection [...]
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CEO Blog
December has always been a great time of reflection.  For me, it’s been a time to  relive my initial 10 [...]
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Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to [...]
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Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable…
The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, [...]
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Rx-360 Announces Susan Bremer as Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for October: Susan Bremer, Corporate Quality Assurance, Lead [...]
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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide
Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product [...]
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5 Strategies To Combat Counterfeit Drugs And Other Pharma Supply Chain Threats
It’s hard enough to detect errors in the entire process of manufacturing and distributing one’s own pharmaceutical products, but pharma [...]
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Mylan and Pfizer Report New Issues Affecting Some EpiPens That Can Delay Treatment
More than a month after Mylan and Pfizer reported to Health Canada that there are new issues affecting some EpiPens, [...]
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FDA Gains New Powers to Block Illicit Drug Imports
A new US law that aims to tackle the national opioid crisis has been welcomed by FDA Commissioner Scott Gottlieb, [...]
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Rx-360 Audit Opportunities
Rx-360 Joint Audit Opportunities Rx-360 is very excited to announce that we will now be releasing all of our Joint [...]
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Rx-360 Announces Tracey Froggatt as Member of the Month!!
Rx-360 is proud to announce our Working Group Member of the Month for September: Tracey Froggatt, Senior Quality Assurance Auditor [...]
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FDA Updates on Valsartan Recalls
FDA releases method for detection and quantification of both NDMA and NDEA Update [10/11/2018] ] FDA is posting a redeveloped combined [...]
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The Uphill Fight Against Fake Prescription Drugs
Tosh Ackerman took part of what he thought was a Xanax pill to help him sleep one night three years [...]
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MHRA Says Falsified Medicines Directive Could Cost £500m Over Ten Years
The Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that implementing the Falsified Medicines Directive (FMD) in the UK [...]
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Rx-360 Announces Jim Henderson As Member of the Month!!
Jim Henderson, Associate Consultant, QA, at Eli Lilly and Company.  Rx-360 would like to thank Jim for his dedication to [...]
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CEO Blog
For many of us, September is a month of remembrance.    For me it is also an opportunity to reflect on [...]
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Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble…
Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center…
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one [...]
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FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in…
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot [...]
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Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida…
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal [...]
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Abbvie Sponsors at Silver Level
Thank you Abbvie for Sponsoring at the Silver level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Register [...]
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URI Chemistry Professor Develops New Contaminant Detection Technique for Blood Thinner Heparin
In 2008, a contaminant eluded the quality safeguards in the pharmaceutical industry and infiltrated a large portion of the supply [...]
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Johnson & Johnson Sponsors at Gold Level
Thank you Johnson & Johnson for Sponsoring at the Gold level at the Rx-360 Global Life Science Supply Chain 2018 [...]
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Rx-360 Global Supply Chain Conference – EARLY BIRD SPECIAL HAS BEEN EXTENDED!!
EARLY BIRD SPECIAL – EXTENDED! It is with great pleasure to announce that Rx-360 has decided to extend the early [...]
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MilliporeSigma Sponsors at Silver Level
Thank you MilliporeSigma for Sponsoring at the Silver level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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Over Half Of U.S. States Have Now Seen Fatalities From Counterfeit Drugs Made With Fentanyl
During a roundtable discussion focused on the nation’s worsening opioid crisis, advocates for ensuring a safe drug supply shared new [...]
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FDA Alerts Drug Makers of a Recall of Porcine Thyroid API from Sichuan Friendly Pharmaceutical…
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, [...]
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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of [...]
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Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due…
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 [...]
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Chinese Vaccine Maker Made 500,000 Substandard Baby Vaccines: Xinhua
A Chinese drug company produced nearly 500,000 substandard vaccines for babies, roughly double an earlier estimate by authorities investigating a [...]
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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg [...]
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Proposed Changes To WHOIS System Privacy Will Help Hide Internet Criminals, NABP Director Warns
Every week brings new details of the negative externalities of social media and e-commerce websites. But fake bots aren’t the [...]
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EMA Reviewing Medicines Containing Valsartan from Zhejiang Huahai Following Detection of an Impurity
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company [...]
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Avantor Sponsors at Bronze Level
Thank you Avantor for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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Rx-360 Announces Tracy Cooper as Working Group Member of the Month!
Rx-360 is proud to announce our Working Group Member of the Month for July: Tracy Cooper, Director, Process Management-CAPA, at [...]
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CEO Blog
Are we on the verge of the next “Heparin contamination scare”? I woke up this morning and like I always [...]
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EU Sees One in 5,000 Cancer Risk from Tainted China Heart Drug
The European Medicines Agency estimates there could be one extra case of cancer for every 5,000 patients taking a common [...]
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BSI Sponsors at Gold Level
Thank you BSI for Sponsoring at the Gold level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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China Heart Drug Sold Globally May Have Had Impurity Since 2012
The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago [...]
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FDA Updates on Valsartan Recalls
Update [8/2/2018] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included [...]
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Takeda Sponsors at Silver Level
Thank you Takeda for Sponsoring at the Silver level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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Could Blockchain Solve China’s Food and Drug Safety Problems?
A scandal involving a Chinese pharmaceutical firm that forged documents relating to a rabies vaccine for babies has sparked a [...]
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CDR TJ Christl, FDA, Will be Presenting During Opening Session!
Rx-360 is pleased to announce that CDR TJ Christl, Director for the Office of Drug Security, Integrity & Response (ODSIR) [...]
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RECALL: Blood Pressure Medication, Valsartan, Recalled Due to Possible Contaminants
The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears [...]
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Outrage in China’s Latest Scandal: Unsafe Vaccines
A scandal over faulty vaccines in China has sparked anger on social media, underscoring the difficulties regulators face in rebuilding [...]
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LifeConEx Sponsors at Silver Level
Thank you LifeConEx for Sponsoring at the Silver level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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Rx-360 Now Has a Toll Free Number!
Rx-360, in an effort to continue improving our communication with our members, and the industry as a whole, now have [...]
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Rx-360 Supply Chain Security Steering Committee Publishes White Paper
The Supply Chain Security Steering Committee is please to announce the release of the white paper “Taking a Collaborative Approach [...]
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Rx-360 Africa GDP Work Group Hosts GDP Workshop in Nairobi, Kenya
The workshop was successfully conducted in Nairobi, Kenya, at the Crowne Plaza Hotel. The attendees were a mix of distributors [...]
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FDA Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food,…
09May2018 FDA issued the draft guidance Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, [...]
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Congratulations to Rx-360’s Quality Manager, Hannah Song on Achieving her ASQ Quality Auditor Certification
Rx-360 would like to congratulate Quality Manager, Hannah Song for achieving her ASQ Quality Auditor Certification.  Rx-360 appreciates Hannah’s hard [...]
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European Union’s General Data Protection Regulation (GDPR)
Rx-360 is committed to protecting your privacy and ensuring you maintain control over your personal information. Rx-360 respects your privacy [...]
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CEO Blog
My First 100 Days:  It’s hard to believe that my first 100 days with Rx-360 is in the books.  My [...]
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Pfizer Sponsors at Bronze Level
Thank you Pfizer for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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TruTag Sponsors at Bronze Level
Thank you TruTag for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference.   [...]
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CEO Blog
Getting Back to Our Roots: During the past week I found myself reading an article from February 2017, titled Global [...]
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Semi Truck, Nearly $1 million in Cancer Drugs Stolen at Tennessee Truck Stop
The Giles County Sheriff’s Office reports nearly $1 million of cancer drugs were stolen with a semi truck on Thursday. [...]
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GSK Sponsors at Bronze Level
Thank you GSK for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference.   [...]
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Boehringer Ingelheim Sponsors at Bronze Level
Thank you Boehringer Ingelheim for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference. [...]
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Rx-360 Supplier Led Working Group Releases All Modules of Supplier Assessment Questionnaire Version 2.0
The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360 [...]
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Congratulations to our Working Group Member of the Month!!
Rx-360, an International Pharmaceutical Supply Chain Consortium, is very pleased to announce our Working Group Member of the Month Award.  [...]
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Sartorius Sponsors at Bronze Level
Thank you Sartorius for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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Rx-360 Supplier Led Working Group Releases Best Practices for Quality Agreements Version 2.0.
The Supplier Led Working Group is pleased to announce the release of Best Practices for Quality Agreements Version 2.0. Quality [...]
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FDA Orders Recall of Salmonella-Tainted Kratom Products Nationwide
Various brands of kratom supplements have been linked to nearly 90 cases of salmonella across 35 states. Click Here to [...]
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CEO Blog
  Networking and Learning: I have always been a big believer in mindset of learning from others, whether they are [...]
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Congratulations to our Working Group Member of the Month!!!
Rx-360, an International Pharmaceutical Supply Chain Consortium, is very pleased to announce our Working Group Member of the Month Award.  [...]
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Sparta Systems Sponsors at Gold Level
Thank you Sparta Systems for sponsoring at the Gold level at the Rx-360 Global Life Science Supply Chain 2018 Conference. [...]
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Exelead Sponsors at Bronze Level
Thank you Exelead for Sponsoring at the Bronze level at the Rx-360 Global Life Science Supply Chain 2018 Conference. Want [...]
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Rx-360’s New Data Integrity Library Resource
About the Data Integrity Library: This library is a collection of up to date publications associated with the topic of data [...]
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Rx-360 Welcomes Newest Manufacturer Member Heron Therapeutics
Rx-360 would like to welcome our newest manufacturer member Heron Therapeutics. We asked several questions to better understand their position [...]
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FDA Office of Pharmaceutical Quality Issues Their Annual Report
On February 28, 2018, FDA’s Office of Pharmaceutical Quality published their first public annual report describing their 2017 accomplishments.  The [...]
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CEO Blog
  Over 20 years ago this month I began my career in the world of healthcare.  At the time I [...]
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Rx-360 Welcomes Newest Manufacturer Member Novo Nordisk
Rx-360 would like to welcome our newest manufacturer member Novo Nordisk. We asked several questions to better understand their position [...]
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WHO Issues Report on Global Surveillance and Monitoring System for Substandard and Falsified Medical Products
On February 14, 2018, the World Health Organization (WHO) issued a report summarizing data gathered by the WHO Global Surveillance [...]
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Rx-360 Supplier Led Working Group Releases Version 2.0 of Product Information Module (Module 3)
The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360 [...]
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Work plan for the joint CHMP/CVMP Quality Working Party (QMP) for 2018
On December 4, 2017, the CHMP/CVMP Working Party issued their final work plan for the joint Quality Working Party (QWP) [...]
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Work Plan for the Biologics Working Party (BWP) for 2018
On December 14, 2017, the EMA published its adopted Work Plan for the Biologics Working Party 2018. The Plan outlines [...]
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