The Orphan Drug Act at 30 Years: What's Next?
30 years ago last week, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases. The anniversary marks the...
View ArticleWoodcock Urges Forward March Toward Personalized Medicine
New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of...
View ArticleThe List So Far: FDA Breakthrough Designations
With announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and...
View ArticleNew Funding and Approval Pathways Prove Popular
By Rita Peters, Editorial Director, BioPharm International. Rita Peters Compared to other manufacturing and technology industries, the bio/pharmaceutical industry has one of the longest product...
View ArticleFDA’s Patient Outreach: Finding Ties that Bind
Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO...
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