Category: Rx-360 Alerts

FDA releases method for detection and quantification of both NDMA and NDEA Update [10/11/2018] ] FDA is posting a redeveloped combined [...]

On December 22, 2017, FDA issued a draft guidance to assist applicants and manufacturers of certain licensed biological products in [...]

On December 28, 2018, FDA announced its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ [...]

On December 26, 2017, FDA issued a Federal Register Notice announcing a proposed program permitting medical device manufacturers to submit malfunction medical [...]

On December 26, 2017, FDA issued a Federal Register Notice announcing a proposed program permitting medical device manufacturers to submit malfunction medical [...]

On December 15, 2017, FDA issued a new, draft guidance that describes how FDA intends to implement provisions enacted by [...]

On December 12, 2017, FDA issued a Federal Register Notice announcing the website location where the Agency will post two lists of [...]

The Manual of Policies and Procedures (MAPP) (effective December 7, 2017) describes how the Center for Drug Evaluation and Research [...]

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PRESS RELEASE Global coalition in the fight against falsified medicines meets in Brussels as it welcomes its 35th partner Monday [...]

On October 3, 2017, FDA issued draft guidance to explain to applicants how the review goals established as part of [...]

On October 3, 2017, FDA issued draft guidance to assist applicants preparing to submit to FDA abbreviated new drug applications [...]

The Supplier Led working group is pleased to announce the release of the final version of the Rx-360 Quality Elements [...]

Abbvie Eli Lilly and Company Sensitech Inc TEVA Pharmaceutical Industries Ltd. MSD McKesson Canada GSK Purdue Pharma Technologies Inc Roche [...]

As you most of the recipients of this information are aware, Puerto Rico and many other locations in the Caribbean [...]

Following the passing of Hurricane Maria on September 20, Puerto Rican news sources have been reporting on widespread damage to [...]

Faith-based organizations (FBOs) provide a substantial portion of the health care services in many African countries. FBO facilities do consider [...]

This alert has been provided by BSI. September 20, 2017 The recent movement of Hurricane Maria over Puerto Rico and [...]

In a collective effort to curb and prevent the circulation of counterfeit drugs in Africa, the Ministers of Health aim [...]

The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360 [...]

On July 20, 2017, FDA announced its intent to establish a pilot project program under the Drug Supply Chain Security [...]

Imperial Logistics Supply Chain Academy’s Receiving Management Program and Inventory Management Program will take place from the 14th – 18th of August 2017 [...]

On July 28th, Fight the Fakes raises awareness around World Hepatitis Day.  According to WHO 2015 World Hepatitis report, 325 million people worldwide [...]

On July 11, 2017, FDA announced a list of class II devices that the Agency has determined based on established [...]

CBER recently published their updated Guidance Agenda for 2017.  The following documents have been added to this updated Guidance Agenda: [...]

22-May-2017 More than 70 per cent of drugmakers believe serialization requirements in the US will positively transform their business processes, [...]

WHA Bans IP Reference In Substandard And Falsified Medicines Intellectual Property Watch … term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC medical products) with “substandard [...]

Nano Pharmaceutical Market Research, Key Players, Industry Overview, Supply and Consumption … DailyNewsKs Nano Pharmaceutical Market is expected to witness growth of international market with respect [...]

FDA has updated the list of guidance documents intended for publication by CDER in 2017.  The only change from the [...]

The European Co-ordination group for Mutual Recognition and Decentralised Procedures has recently published a set of Q&As related to QP [...]

The European network of Official Medicines Control Laboratories has highlighted how new analytical techniques will support national authorities, such as [...]

EMA has recently published additional questions and answers related to whether or not variations are required for removal of the [...]

If the FDA has serious concerns about the APIs or drugs made at a facility outside the U.S., it often will [...]

The Monitoring and Reporting Group has just launched three more resources to the resource library. We invite you to share these [...]

Counterfeit drugs are putting the whole world at risk Popular Science A blister pack of faked Artesunate, a drug used to treat malaria, [...]

By Marex  2017-02-23 14:01:00 The International Longshoremen’s Association (ILA) is calling for a shutdown at ports along the eastern seaboard and Gulf [...]

Report provided by the Transported Asset Protection Association TAPA Americas collects, records, analyzes and reports on cargo theft data for [...]

Securing Industry 18FEB2017 – Axicorp GmbH has discovered another falsified medicine in the legitimate supply chain in Germany, this time [...]

Drug-peddling brothers from Lithuania ran international counterfeit medicine scam from Oxford … Oxford Mail Enforcement officers raided the house and storage [...]

We are very pleased to inform you that the USP is announcing the availability of a CoE Pilot Program on [...]

Barb Unger, of Unger Consulting Inc., has written a superb article that makes sense of all the complicated and obscure [...]

FDA has recently issued a final guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing [...]

As of December 31, 2016, the National Association of Boards of Pharmacy has reviewed over 11,000 websites selling prescription medicine [...]

ALBANY, GA (WALB) -Justice Department officials say they are concerned that more Americans are buying medication illegally from foreign pharmacies, and [...]

The World Health Organization (WHO) estimates that about 10 per cent of global pharmaceutical supply is counterfeit and substandard. The [...]

On January 11, 2017, MHRA published the 2015 GMP inspection deficiency data trend. The top 10 most cited deficiency groups [...]

CDER has published their CY2017 Guidance Agenda, which outlines new and revised draft guidances CDER plans to publish during the [...]

On November 8, 2016, FDA issued final guidance to describe and explain FDA’s current regulation that addresses reporting and record keeping [...]

On December 23, 2016, FDA modified the list of standards FDA recognizes for use in pre-market reviews (“FDA Recognized Consensus Standards”). [...]

On December 28, 2016, FDA issued final guidance to inform industry and FDA staff of the Agency’s recommendations for managing [...]