Search Results for track and trace

Showing 1 – 25  of 34

ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

FDA Offers Draft Guidance to Further Secure Drug Supply Chain By Zachary Brennan - Published 21 August 2017

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging, Regulatory strategy

Tags: DSCSA, track and trace, FDA guidance, drug supply chain

FDA Delays Enforcement of Product Identifier Requirements By Zachary Brennan - Published 30 June 2017

In a draft guidance published Friday, the US Food and Drug Administration (FDA) says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: DSCSA, track and trace, FDA draft guidance

FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section By Zachary Brennan - Published 08 December 2016

The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: DSCSA, track and trace, supply chain pharmaceuticals, FDA guidance

Companies Collaborate on DSCSA Guideline as Deadlines Approach By Zachary Brennan - Published 22 November 2016

Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Business Skills, Distribution, Drugs, Government affairs, Labeling, Project management

Tags: GS1, traceability, pharmaceutical track and trace, serialization, DSCSA

New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect By Zachary Brennan - Published 29 February 2016

Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Due Diligence, Manufacturing, Postmarket surveillance, Quality

Tags: first responders, track and trace, DQSA, DSCSA, dispensers, pharmacies

Asia Regulatory Roundup: India Pushes Back Track and Trace Deadline Again (12 January 2016) By Nick Paul Taylor - Published 12 January 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Manufacturing, Regulatory strategy

Tags: CDSCO, India, CFDA, track and trace

FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements Published 30 June 2015

The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA).

Categories: News, US, CDER, Biologics and biotechnology, Distribution, Drugs

Tags: Track and Trace, DQSA, DSCSA, Guidance, Draft Guidance

India Says Other Regulators Will Have Access to Export Database By Michael Mezher - Published 25 June 2015

India is planning to make a database used to track drug exports available to regulators and companies around the world, The Economic Times reports.

Categories: News, India, CDSCO, Drugs, Labeling, Quality

Tags: Track and Trace, Spurious drugs

Anvisa Demonstrates New Drug Tracking Platform By Louise Zornoza, RegLink News - Published 09 October 2014

Anvisa has unveiled Brazil's first drug tracking platform - a step in the implementation of the National Drug Control System (SNCM) - providing an interface between the agency and the holders of drug registrations.

Categories: News, Latin America and Caribbean, Anvisa, Labeling, Packaging

Tags: Track and Trace

Brazilian Regulator Anvisa Issues New Track and Trace Guidance By Louise Zornoza, RegLink News - Published 20 August 2014

Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM). 

Categories: News, Latin America and Caribbean, Anvisa, Biologics and biotechnology, Drugs

Tags: Track and Trace, SNCM, National Drug Control System

As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: 503(b)(1), Prescription Drug, Alli, Drug Quality and Security Act, DQSA, OTC, GSK, Track and Trace, Latest News, pharmaceutical, drug

Anvisa Approves Track and Trace System By Louise Zornoza, RegLink - Published 11 December 2013

Categories: Anvisa

Tags: Traceability, Track, Trace, Track and Trace, brazil

Track and Trace, Compounding Legislation Passes Senate, Awaits President's Signature By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: Drug Quality and Security Act, DQSA, Pharmaceutical Compounding, Compounding, Track and Trace, Legislation, Latest News

New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace By Alexander Gaffney, RF News Editor - Published 26 September 2013

Categories: US, FDA

Tags: Compounding, Track and Trace, Legislation

As US Congress Returns to Washington, Senator Calls for Work to Resume on Track and Trace Measures By Alexander Gaffney, RF News Editor - Published 12 September 2013

Tags: Track and Trace

Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace By Alexander Gaffney, RF News Editor - Published 26 July 2013

Categories: US

Tags: Compounding, Track and Trace, Legislation, Senate

Global Tracking Regulations Present Challenges and Benefits By Torben Vogt and Mari Serebrov - Published 16 July 2013

Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization.

Tags: Track, Trace, Track and Trace, Serialization, pharmaceutical, drug

Track and Trace Passes House of Representatives with Major Support, Now Moves to Senate By Alexander Gaffney, RF News Editor - Published 04 June 2013

Categories: US, FDA

Tags: Track and Trace, Legislation

Costs of Proposed Pharmaceutical Track and Trace System Come into Focus for FDA, Industry By Alexander Gaffney, RF News Editor - Published 03 June 2013

Categories: US, FDA

Tags: CBO, Track and Trace

Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage By Alexander Gaffney, RF News Editor - Published 23 May 2013

Categories: US

Tags: Pharmaceutical Compounding, Compounding, Track and Trace, User Fees, Legislation, Latest News, Senate

Woodcock: FDA Strongly Supports Pharmaceutical Track and Trace By Alexander Gaffney, RF News Editor - Published 26 April 2013

Categories: US, FDA

Tags: Track and Trace, Janet Woodcock, Latest News, pharmaceutical, drug

Senate Track and Trace Legislative Draft Includes Lot-Level Requirements and New Penalties By Alexander Gaffney, RF News Editor - Published 22 April 2013

Tags: Track and Trace, pharmaceutical, drug

PhRMA, GPhA Call for Revival of Pharmaceutical Track and Trace Measures By Alexander Gaffney, RF News Editor - Published 03 April 2013

Categories: US, FDA

Tags: FDASIA, Traceability, Track and Trace, Counterfeit, GPhA, PhRMA, Latest News

Senate Releases Draft Proposal of National Track and Trace System By Alexander Gaffney, RF News Editor - Published 25 October 2012

Tags: HELP Committee, Track and Trace, Legislation, Latest News, Serialization, Congress, draft