Search Results for Errors

Showing 1 – 13

Mistake-Proofing the Workplace By Zachary Sherman, Max Sherman - Published 22 September 2017

This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.

Categories: Features, Compliance, Manufacturing, Quality

Tags: Errors, Defects, Quality

ICH Working Group to Provide More Detailed Guidance By Zachary Brennan - Published 23 January 2017

The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.

Categories: News, Canada, Europe, US, ICH, Clinical, Crisis management, Drugs, Quality

Tags: MedDRA, pharmaceutical company guidance, medication errors

Confusion Pushes FDA to Change Antidepressant’s Brand Name By Zachary Brennan - Published 02 May 2016

The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor).

Categories: News, US, FDA, Advertising and Promotion, Compliance, Labeling, Regulatory intelligence

Tags: brand name change, medication errors, Brinellix, Brilinta

Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors By Michael Mezher - Published 11 April 2016

The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug's container closure system to minimize the risk of medication errors.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs

Tags: Medication errors

FDA: Brand Name Confusion Led to Dozens of Medication Errors By Michael Mezher - Published 31 July 2015

The US Food and Drug Administration (FDA) has issued a safety alert for two drugs, Brintellix and Brilinta, after receiving 50 reports of confusion between them caused by similarities in the drugs' names.

Categories: News, US, FDA, Drugs, Labeling, Postmarket surveillance

Tags: Brand names, Proprietary names, Drug naming, Medication errors, Brintellix, Brilinta

Plain Language Labeling Regulations to Take Effect in Canada By Michael Mezher - Published 02 June 2015

Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Labeling, Packaging, Submission and registration

Tags: Plain language labeling, Medication errors, Adverse drug reactions, ADRs

EMA Releases Draft Guides to Reduce and Report Medication Errors By Michael Mezher - Published 16 April 2015

To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors.

Categories: News, Europe, EMA, ICH, Combination products, Drugs, Due Diligence, Labeling, Packaging, Postmarket surveillance

Tags: Medication errors, Good vigilance practice, pharmacovigilance, GVP

EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward By Alexander Gaffney, RF News Editor - Published 23 May 2013

Categories: EMA

Tags: Medication Errors, Report, Latest News, workshop, EU

FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors By Alexander Gaffney, RF News Editor - Published 23 April 2013

Categories: US, FDA, Labeling

Tags: Carton, Medication Errors, Latest News, label, draft guidance, safety, guidance

New Emphasis on Reducing Medication Errors to Have Regulatory Implications, Says EMA By Alexander Gaffney, RF News Editor - Published 04 March 2013

Categories: EMA

Tags: Medication Errors, Adverse Events, Latest News, EU, pharmacovigilance

New Guidance Aims to Reduce Medication Errors Through Better Preapproval Testing By Alexander Gaffney, RF News Editor - Published 12 December 2012

Categories: FDA

Tags: Medication Errors, User Testing, Latest News, pharmaceutical, draft guidance, drug

Study: Diagnostic Errors Death Equal Breast Cancer Deaths Published 31 August 2012

Tags: ICU, Johns Hopkins, Errors, Death, Breast Cancer, Latest News, diagnostic

EMA Issues Guidance on Risk Assessment of Potential Medication Errors By Alexander Gaffney - Published 04 June 2012

Categories: EMA

Tags: Errors, Reformulated, Medication, Benefit, Generic, Latest News, pharmaceutical, drug, risk