Regulations for Orphan Drug Research

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Regulations for Orphan Drug Research – This is a place for the community to provide tips and advice on Regulations for Orphan Drug Research. This topic was created by Gareth Williams and the tips are provided by the community. The tips you add here can be your own or referred from another site. The best tips are then ranked at the top when up-voted by members of the community.

Tip 1 - Orphan drug: Development trends and strategies

Published: 9 years, 6 month(s) ago | Submitted by Mark Coletti | permalink

The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity ...

For further reading: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2996062/ ^[1]

Tip 2 - Premier Research's New Survey of Rare Diseases, Orphan Drugs Highlights Regulatory Challenges - Premier Research

Published: 9 years, 6 month(s) ago | Submitted by Michael Mc Donagh | permalink

A new survey of clinical trial decision makers commissioned by Premier Research reports that nearly two-thirds (64%) of respondents said that among the most difficult factors in recruiting for a rare disease or orphan drug clinical trial was not only finding patients to join and remain in trials, but identifying and setting up investigative sites for studies.

For further reading: http://premier-research.com/premier-researchs-new-survey-of-rare-diseases-orphan-drugs-highlights-regulatory-challenges/ ^[2]