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Filtering on: "topics veterinary products"

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European Regulatory Roundup: Roche Escapes Penalty for Breaching EU Pharmacovigilance Rules (21 December 2018) By Nick Paul Taylor - Published 21 December 2017

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

Categories: News, Canada, EC, EMA, MHRA, WHO, Biologics and biotechnology, Drugs, Postmarket surveillance, Veterinary products

Tags: EU Regulatory Roundup, Roche, Gates Foundation

Health Canada Seeks to Update User Fees for Drug and Device Firms By Zachary Brennan - Published 13 October 2017

Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Submission and registration, Veterinary products

Tags: pharmaceutical fees, medical device fees, Health Canada fees

European Regulatory Roundup: EMA Adopts Revised First-in-Human Trial Guidance; UK Appoints Industry Veteran Ahead of Negotiations with Pharma (27 July 2017) By Nick Paul Taylor - Published 27 July 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Blood, Clinical, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup

European Regulatory Roundup: Dutch MEB Raises Concerns About use of ADHD Drug Ritalin in Adults (27 April 2017) By Nick Paul Taylor - Published 27 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, Drugs, Veterinary products

Tags: European Regulatory Roundup, CVMP, MEB

European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (23 March 2017) By Nick Paul Taylor - Published 23 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Reimbursement, Veterinary products

Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup

European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (23 February 2017) By Nick Paul Taylor - Published 23 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, EMA, MHRA, Advertising and Promotion, Biologics and biotechnology, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

What's Happening Down Under? The Australian Regulatory Scene in 2016 By Clive Simon, PhD, MBA - Published 13 June 2016

This article discusses the current regulatory framework for drugs and medical devices in Australia, compares differences in regulatory processes between Australia, the US and the EU and predicts future developments and challenges for industry and regulators.

Categories: Features, Oceania, TGA, Biologics and biotechnology, Cosmetics, Over the counter drugs, Prescription drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products

European Regulatory Roundup: EMA Plans Ways to Curb Antibiotic Resistance (2 June 2016) By Nick Paul Taylor - Published 02 June 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Manufacturing, Veterinary products

Tags: EU Regulatory Roundup, antibiotic resistance, synthetic opioids

Company Calls on FDA to Speed Authorization of Genetically Modified Mosquitoes to Fight Zika Virus By Zachary Brennan - Published 25 May 2016

As the US Food and Drug Administration (FDA) continues to debate whether to allow Britain’s Oxitec to release genetically modified mosquitoes into Florida and other vulnerable areas as a means of controlling the spread of the Zika virus, the company’s CEO told a House committee Wednesday that time is running out.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Veterinary products

Tags: Oxitec, GM mosquitoes, genetically modified mosquitoes, mosquito control

FDA: 'No Significant Impact' to Environment From Genetically Engineered Mosquito Trial By Michael Mezher - Published 11 March 2016

The US Food and Drug Administration (FDA) on Friday said that a proposed trial to release genetically engineered mosquitoes in Key Haven, FL poses no significant threat to the environment.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Veterinary products

Tags: Oxitec, OX513A, Aedes aegypti, Environmental assessment, EPA

European Regulatory Roundup: Parliament Seeks More Responsible Use of Antibiotics (10 March 2016) By Nick Paul Taylor - Published 10 March 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Veterinary products

Tags: European Regulatory Roundup, EU medical news, antibiotics, monoclonal antibodies

European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016) By Nick Paul Taylor - Published 25 February 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Crisis management, Drugs, Government affairs, Preclinical, Veterinary products

Tags: EMA, Brexit, antibiotic use, ENVI, CVMP

European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016) By Nick Paul Taylor - Published 11 February 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Veterinary products

Tags: NICE, Xarelto, Paluent, Sanofi, Amgen, ENVI

European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016) By Nick Paul Taylor - Published 04 February 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Veterinary products

Tags: database of off-label treatments, UK legislation, pandemic vaccines, CRISPR

European Regulatory Roundup: MHRA Phasing Out Use of CDs, DVDs in Submissions (30 November 2015) By Nick Paul Taylor - Published 30 November 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Combination products, Drugs, Manufacturing, Research and development, Veterinary products

Tags: MHRA, EMA, Adaptive Pathways, CVMP, CHMP

European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015) By Nick Paul Taylor - Published 22 October 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, ICH, Drugs, Due Diligence, Postmarket surveillance, Quality, Regulatory intelligence, Research and development, Veterinary products

Tags: EMA, MEB, CHMP, veterinary antibiotics, ICH, Pradaxa

FDA Unveils User Fee Rates for FY2016 By Michael Mezher - Published 04 August 2015

The US Food and Drug Administration (FDA) has just released the rates for the various user fees charged to industry for fiscal year 2016.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Submission and registration, Veterinary products

Tags: PDUFA, MDUFA, GDUFA, ADUFA, AGDUFA, User fees

EMA: Revised Rules for GCP and Veterinary Type IA Fees Take Effect By Michael Mezher - Published 30 July 2015

The European Medicines Agency (EMA) is reminding companies that beginning 1 August 2015, several changes to its implementing rules on fees payable to the agency will enter into force.

Categories: News, Europe, EMA, Clinical, Drugs, Regulatory strategy, Veterinary products

Tags: Fees, Good clinical practice, GCP

Electronic Application Forms Mandatory for EU Centralized Procedure By Michael Mezher - Published 01 July 2015

Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration, Veterinary products

Tags: Electronic application forms, eAF, eSubmission

EMA Issues Recommendations for Veterinary Pharmacovigilance, Signal Detection By Michael Mezher - Published 11 June 2015

The European Medicines Agency (EMA) has released a new set of recommendations for postmarket surveillance for veterinary medicinal products, which will go into effect on 1 October 2015.

Categories: News, Europe, EMA, Drugs, Postmarket surveillance, Regulatory strategy, Veterinary products

Tags: Pharmacovigilance, Signal management

FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation By Alexander Gaffney, RAC - Published 03 June 2015

US and Canadian healthcare product regulators are continuing to move forward in a joint effort to harmonize the way in which both countries regulate pharmaceuticals, medical devices, biological products and veterinary drugs.

Categories: News, Canada, US, FDA, Health Canada, Biologics and biotechnology, Drugs, Medical Devices, Veterinary products

Tags: RCC, Regulatory Cooperation Council, Harmonization

FDA Finalizes Policy Meant to Limit Use of Antibiotics in Farm Animals By Alexander Gaffney, RAC - Published 02 June 2015

The US Food and Drug Administration (FDA) has released a long-anticipated final rule meant to limit the use of antibiotics in food-producing animals in order to limit the spread of antibiotic-resistant bacteria.

Categories: News, US, FDA, Distribution, Veterinary products

Tags: VFD, Veterinary Feed Directive, Antibiotics, Antimicrobials

Australia Releases Updated Drug Schedule By Michael Mezher - Published 01 June 2015

Australia has updated a legislative instrument designed to advise the country's states and territories on the scheduling and labeling of medicines and poisons.

Categories: News, Oceania, TGA, Biologics and biotechnology, Cosmetics, Distribution, Drugs, Labeling, Nutritional and dietary supplements, Packaging, Veterinary products

Tags: Drug schedule, The Poison Standard, SUSMP, Standard for the uniform scheduling of medicines and poisons

EU Committee Takes on Adverse Event Reporting for Veterinary Drugs By Michael Mezher - Published 20 March 2015

Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting.

Categories: News, Europe, EMA, Drugs, Postmarket surveillance, Veterinary products

Tags: Adverse Event Reporting, AERs, Food-producing animals, CVMP, VICH

In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help By Michael Mezher - Published 16 March 2015

The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals.

Categories: Drugs, Postmarket surveillance, Veterinary products

Tags: Antimicrobial Resistance, AMR, European Surveillance of Veterinary Antimicrobial Consumption, ESVAC, defined daily dose, defined course dose