FDA GUIDANCE ON BISPECIFIC ANTIBODY DEVELOPMENT
Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies having two distinct binding domains capable of binding two different antigens or…
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AIR PURIFIERS AND AIR DECONTAMINATORS: ARE THEY MEDICAL DEVICES OR NOT?
In the context of the COVID-19 pandemic, great attention is given to the sanitation measures of people and environments. People…
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FDA GUIDANCE ADDRESSES PATIENT OUTCOMES IN CANCER CLINICAL TRIALS
Involvement of patients is becoming a fundamental principle throughout drug development and during regulatory advice and assessment. Patients have been…
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NEW AIFA PRICING AND REIMBURSEMENT E-DOSSIER PORTAL GOES LIVE
A new electronic interface for the preparation of Pricing and Reimbursement e-Dossiers has been developed by AIFA and has become available since 31st May…
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5% PAYBACK – LATEST NEWS
In Italy, with a few exceptions, the public price (VAT included) of medicines reimbursed by the NHS is subject to…
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CLINICAL TRIALS – UPDATE OF SUBMISSION PROCEDURE AND AUTHORIZATION FORMS
The Italian Medicines Agency (AIFA) has published an update concerning the documentation for the submission of Phase I, II, III…
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PHARMACOVIGILANCE – MANAGEMENT OF REPORTS OF LACK OF EFFICACY IN THE NATIONAL PHARMACOVIGILANCE NETWORK
The Italian Medicines Agency (AIFA), in line with what is reported in the Guideline on good pharmacovigilance practices (GVP) Module…
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SCIENTIFIC RECOMMENDATIONS ON CLASSIFICATION OF ADVANCED THERAPY MEDICINAL PRODUCTS
Advanced therapy medicinal products (ATMPs) consist of products that contain recombinant nucleic acids or engineered cells and/or tissues representing a…
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EU REGULATION 2017/745 AND SWITZERLAND
May 26th, 2021 has been the official day for the entry into force of the new regulation of medical devices…
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CONFIDENTIALITY ARRANGEMENT BETWEEN EU AND BRAZILIAN REGULATORY AUTHORITIES
The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) signed a confidentiality…
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