2015 Approvals Herald Rapid Progress, Growing Diversity in Precision Medicine

2020-10-06T03:32:57-05:00

The Personalized Medicine Coalition (PMC) reports that 13 of 45 new molecular entities or therapeutic biologics approved by FDA in 2015, or 28%, were personalized medicines. The number of approved personalized (precision) medicines increased from 9 in 2014. While completing the transition to precision medicine will take years and require addressing major challenges, the momentum [...]

2015 Approvals Herald Rapid Progress, Growing Diversity in Precision Medicine2020-10-06T03:32:57-05:00

Debunking the Instant Myth of FDA as Rubber Stamp

2020-10-06T03:40:23-05:00

FDA's high approval rate for New Drug Applications (NDAs) is much in the news, with headlines like the one on a Matthew Herper post at Forbes: The FDA Is Basically Approving Everything. Here's the Data to Prove It. The data comes from an analysis that Forbes commissioned at BioMedTracker. When FDA approves 23 out of [...]

Debunking the Instant Myth of FDA as Rubber Stamp2020-10-06T03:40:23-05:00

Independent Pre-FDA Draft Guidances from Stakeholders

2020-10-06T03:40:47-05:00

The introduction to an FDA draft guidance for industry published in June 2015, "Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment," makes an unusual statement: Development of this guidance was preceded by the submission to FDA of a proposed draft guidance independently prepared by a consortium of stakeholders including patients, parents and caregivers, clinicians, [...]

Independent Pre-FDA Draft Guidances from Stakeholders2020-10-06T03:40:47-05:00
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