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FDA Draft Guidance – Rare Diseases: Common Issues in Drug Development

FDA Draft Guidance – Rare Diseases: Common Issues in Drug Development

by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Real Word Evidence

The FDA has published a draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” The purpose of this draft guidance (January 2019) is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in...
FDA Draft Guidance – Natural History Studies

FDA Draft Guidance – Natural History Studies

by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Registry

The Food and Drug Administration (FDA or Agency) has announced (27 March 2019) the availability of a draft guidance for industry entitled “Rare Diseases: Natural History Studies for Drug Development.” FDA is publishing this draft guidance to help inform the design and...

EU – List of Products Granted Eligibility to PRIME

by chuck_ltd | 7 Mar, 2017 | CHCUK News & Articles, EAP, Orphan Drugs, Rare Diseases, Real Word Evidence

PRIME (PRIority MEdicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of...

Recent Changes to the Orphan Drug Guidelines

by chuck_ltd | 11 Jan, 2017 | CHCUK News & Articles, News, Orphan Drugs, Rare Diseases

The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years,...

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