Researchers Link Target Product Profiles to Shorter Review Times
By Michael Mezher -
Published 17 April 2017
A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.
Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration
Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP
Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps
By Daniel Muscionico, PharmD, MPH, MBA, Paloma Grasser, MTIM, BSc, Rosa Mouchotte, MSc, RAC, Anne Rambaud -
Published 29 April 2016
This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps.
Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory strategy, Reimbursement
Tags: Health technology assessment, HTA, Reimbursement, Market access, EUnetHTA, Target product profile