Search Results for AIFA

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Italy Reimbursement Profile By Patrizia Berto, PharmD, MBA - Published 14 September 2017

This profile summarizes the reimbursement process in Italy, presents key stakeholders and highlights what should be considered early in the development process.

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

Tags: AIFA, Agenzia Italiana del Farmaco, Reimbursement

Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations By Michael Mezher - Published 31 January 2017

The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December.

Categories: News, Europe, Latin America and Caribbean, Drugs, Manufacturing, Quality

Tags: AIFA, Italian Medicines Agency, Antibioticos do Brasil, ABL

European Regulatory Roundup: Italy Fines Aspen $5.7M for Increasing Cancer Drug Prices by 1,500% (20 October 2016) By Nick Paul Taylor - Published 20 October 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, Crisis management, Drugs, Due Diligence, Manufacturing, Quality

Tags: Remicade, Celltrion, Aspen, AIFA, NIBSC

Italian Medicines Agency Finds Major Deficiencies at Radiopharmaceutical Manufacturer By Zachary Brennan - Published 02 December 2015

The Italian Medicines Agency (AIFA) released a non-compliance report on Wednesday for the Rome-based radiopharmaceutical manufacturer Iason Italia with deficiencies linked to quality issues.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Manufacturing, Quality

Tags: AIFA, Italian Medicines Agency, Iason, Italian pharmaceutical manufacturing, radiopharmaceuticals

Italian Regulators Call for Clinical Data to be Disaggregated by Gender By Alexander Gaffney, RF News Editor - Published 05 February 2013

Tags: AIFA, Clinical Data, Italy

Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines By Alexander Gaffney, RF News Editor - Published 26 October 2012

Tags: AEMPS, SwissMedic, AIFA, Flaud, Agrippal, Vaccine, Influenza, Flu, Novartis, Latest News