Category: Rx-360 Alerts

Industry News Headlines
Drug-peddling brothers from Lithuania ran international counterfeit medicine scam from Oxford … Oxford Mail Enforcement officers raided the house and storage [...]
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Securing Medical Product Quality Through the Supply Chain
We are very pleased to inform you that the USP is announcing the availability of a CoE Pilot Program on [...]
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An Analysis of FDA FY2016 Drug GMP Warning Letters
Barb Unger, of Unger Consulting Inc., has written a superb article that makes sense of all the complicated and obscure [...]
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FDA Final Repackaging Guidance
FDA has recently issued a final guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing [...]
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96% of Websites Selling Prescription Drugs Found to Be Operating Illegally
As of December 31, 2016, the National Association of Boards of Pharmacy has reviewed over 11,000 websites selling prescription medicine [...]
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FDA says investigations underway into counterfeit medications
ALBANY, GA (WALB) -Justice Department officials say they are concerned that more Americans are buying medication illegally from foreign pharmacies, and [...]
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Strict vetting can help fight counterfeit drugs
The World Health Organization (WHO) estimates that about 10 per cent of global pharmaceutical supply is counterfeit and substandard. The [...]
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MHRA Publishes 2015 GMP Inspection Deficiency Data
On January 11, 2017, MHRA published the 2015 GMP inspection deficiency data trend. The top 10 most cited deficiency groups [...]
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CDER Issues Guidance Agenda for CY 2017
CDER has published their CY2017 Guidance Agenda, which outlines new and revised draft guidances CDER plans to publish during the [...]
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FDA Issues Final Guidance on Medical Device Reporting for Manufacturers
On November 8, 2016, FDA issued final guidance to describe and explain FDA’s current regulation that addresses reporting and record keeping [...]
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Modifications to the List of FDA Recognized Standards
On December 23, 2016, FDA modified the list of standards FDA recognizes for use in pre-market reviews (“FDA Recognized Consensus Standards”). [...]
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FDA Issues Final Guidance Postmarket Management of Cyber Security in Medical Devices
On December 28, 2016, FDA issued final guidance to inform industry and FDA staff of the Agency’s recommendations for managing [...]
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FDA Issues Final Guidance on Medical Device Accessories
On Friday, December 30, 2016, FDA issued final guidance is intended to provide guidance to industry and FDA staff about [...]
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Has the Insolvency of Hanjin Shipping Negatively Impacted Your Shipments?
Hanjin Shipping is a large shipping company based out of South Korea. Pursuant to many news reports, Hanjin had many [...]
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FDA Takes Action Banning Imports From 4 Indian and Chinese Firms Under GDUFA’s User Fee…
The FDA on Wednesday banned imports from Chinese and Indian generic drug companies because they failed to pay fees and [...]
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Concerns of Rising China Drug Sales in the United States
As recently reported by Bloomberg: China Drug Sales to the U.S. Grow Despite Safety Concerns at Home Yet even as [...]
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FDA Published the Quality Metrics Technical Conformance Guide
On June 27, 2016, FDA published the Quality Metrics Technical Conformance Guide – Technical Specifications Document Version 1.0 (Guide).  This [...]
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EMA Publishes Update to “Quality of Medicines Questions and Answers Part 1″
The European Medicines Agency (EMA) published a new question and answer on July 29, 2016 regarding Active Substance – Active Substance [...]
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FDA Publishes Modifications to the List of Recognized Standards
The FDA has modified the list of standards FDA recognizes for use in pre-market reviews (“FDA Recognized Consensus Standards”).  Specifically, this publication [...]
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EMA Questions and Answers: Good Manufacturing Practice – Data Integrity
The European Medicines Agency has released new GMP guidance to ensure the integrity of data that are generated in the [...]
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FDA warns consumers of risks of online pharmacies
The Food and Drug Administration is warning U.S. consumers that the vast majority of Internet pharmacies are fraudulent and likely [...]
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Summary of the Draft WHO HVAC GMPs for Non-Sterile Products
WHO has issued a revision to their supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceutical dosage forms.  This [...]
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Rx-360 Applauds Law Enforcement and Regulatory Authorities Involved in a Successful PANGEA IX
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action [...]
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Medical Device User Fee and Modernization Act
On December 29, 2015, FDA announced the web site location where the Agency will post two lists of guidance documents [...]
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Public Notification of Emerging Postmarket Medical Device Signals
On December 31, 2015, FDA published a draft guidance describing the Agency’s policy for notifying the public about medical device [...]
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