Search Results for France

Showing 1 – 25  of 34

France Reimbursement Profile By Jenifer Ehreth, MHA, PhD - Published 20 September 2017

This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process.

Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement

Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France

FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors By Zachary Brennan - Published 12 August 2016

The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs, Product withdrawl and retirement, Regulatory intelligence

Tags: Bial, Biotrial, France Phase 1 study, clinical trials, FAAH inhibitors

Phase I Death in France: An Update on ANSM’s Investigations By Zachary Brennan - Published 05 February 2016

New information from France’s National Agency for Medicines and Health Products Agency (ANSM) was released this week on the Phase I clinical trial halted last month after the death of one healthy volunteer and the hospitalizations of five others.

Categories: News, Europe, EMA, Clinical, Crisis management, Drugs, Quality, Research and development

Tags: ANSM, Bial, Biotrial, France clinical trial

EMA Will Assess ANSM Review of Botched Clinical Trial in France By Zachary Brennan - Published 19 January 2016

EU authorities could end up revising clinical trial guidelines depending on the outcome of French regulators’ investigation into Biotrial’s halted Phase I trial that has resulted in the death of one volunteer and the hospitalizations of five others.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Ethics, Government affairs, Project management, Research and development

Tags: ANSM, Biotrial, EMA, Bial, clinical trial in France

France’s ANSM Investigating Trial Halted After Five Patients Hospitalized, One Brain-Dead By Zachary Brennan - Published 15 January 2016

France’s National Agency for Medicines and Health Products Safety (ANSM) is currently investigating a Phase I clinical trial that’s been halted after the investigational drug caused brain damage in one healthy volunteer and hospitalized five others.

Categories: News, Europe, EMA, Clinical, Crisis management, Drugs, Due Diligence, Quality, Regulatory strategy

Tags: ANSM, France, clinical trial, Biotrial, Rennes

French Regulators Suspend Catalent Manufacturing Site By Zachary Brennan - Published 16 November 2015

France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday.

Categories: News, Europe, Distribution, Drugs, Due Diligence, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANSM, France, French drug regulator, Catalent, softgel capsules

French Regulators Find Cargill Manufacturing Site Non-Compliant With GMPs By Zachary Brennan - Published 02 November 2015

France’s National Agency for Medicines and Health Products Safety (ANSM) has uncovered deficiencies at Cargill’s manufacturing site in Lannilis, France that have resulted in a major recall.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANSM, Cargill, excipients, alginic acid, Topaal, France drug manufacturing

French Regulator and Roche Trade Blows Over Off-Label Avastin Use By Michael Mezher - Published 25 June 2015

On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015.

Categories: News, Europe, Biologics and biotechnology, Labeling, Submission and registration

Tags: France, ANSM, Roche, Avastin, Lucentis, Wet AMD

After US Compounding Fiasco, France Confronts Similar Safety Crisis By Alexander Gaffney, RAC - Published 24 January 2014

Tags: France, EU

French Regulators Issue Warning About Celgene's Abraxane By Alexander Gaffney, RAC - Published 23 January 2014

Tags: France, EU

Safety Concerns Assuaged, Birth Control Pill Back on the Market in France By Alexander Gaffney, RAC - Published 14 January 2014

Tags: France, EU

Executives of Company Accused of Pulling Wool Over Eyes of EU Regulators Sentenced to Prison By Alexander Gaffney, RF News Editor - Published 10 December 2013

Tags: Prison, Breast Implant, PIP, France, EU

French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices By Alexander Gaffney, RF News Editor - Published 15 May 2013

Tags: ANSM, France, cardiovascular, EU, medical device

French Regulator Back in Spotlight as Another Device is Alleged to Have Evaded Controls By Alexander Gaffney, RF News Editor - Published 03 May 2013

Tags: ANSM, France, French, medical device

French Regulator Charged with Manslaughter for Role in Diabetes Drug Scandal By Alexander Gaffney, RF News Editor - Published 22 March 2013

Tags: ANSM, Indictment, Servier, Mediator, Investigation, France, French, Latest News

France: Reimbursement Review Launched for Spinal Neurostimulation Devices By Louise Zornoza, RegLink - Published 16 January 2013

Tags: HAS, France

France Releases Knee Joint Implant Reimbursement Recommendations By Louise Zornoza, RegLink - Published 02 January 2013

Categories: Reimbursement

Tags: Knee, France

CEO Charged with Manslaughter after Drug's Risks Brought to Light By Alexander Gaffney, RF News Editor - Published 12 December 2012

Tags: ANSM, Servier, AFSSAPS, France, French

French Executive Released from Prison to Await Trial over Regulatory Fraud Published 30 October 2012

Tags: Mas, Implants, Breast Implant, PIP, France, French, Latest News, medical device

France's ANSM Announces Launch of Nine Regulatory Pilot Projects By Alexander Gaffney, RF News Editor - Published 29 October 2012

Tags: Pilot Projects, ANSM, Funding, France, Latest News, regulatory

France Clarifies Its Health Technology Assessment Process By Ansis Helmanis, RegLink - Published 22 October 2012

Tags: HAS, cost, France, Latest News, guidance

French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use By Alexander Gaffney - Published 08 October 2012

Tags: TRU, ANSM, Prescribing, Mediator, AFSSAPS, Off-label, France, Latest News

France: HAS Posts Overview of HTA Public Consultations By Louise Zornoza, RegLink - Published 06 June 2012

Categories: Regulatory Update, NICE

Tags: Public Consultations, HAS, HTA, France

France Issues New Advertising Guidelines By Alexander Gaffney - Published 04 June 2012

Tags: Preapproval, Visa PM, Visa GP, ANSM, OTC, France, Latest News, pharmaceutical, marketing, advertising, drug, regulatory

New French Regulatory Agency Announces Transition of Leadership By Alexander Gaffney - Published 03 May 2012

Tags: Leader, Maraninchi, MSNA, Created, Abadie, CEO, AFSSAPS, France, French, Latest News