Regulations for Orphan Drug Research

Submit Your Tip

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.

Votes

Tips

1
- Vote
Tip 1
Orphan drug: Development trends and strategies More
Published: 9 years, 6 month(s) ago by Mark Coletti | permalink
Vote
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]

1
- Vote
Tip 2
Premier Research's New Survey of Rare Diseases, Orphan Drugs Highlights Regulatory Challenges - Premier Research More
Published: 9 years, 6 month(s) ago by Michael Mc Donagh | permalink
Vote
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]