Debunking the Instant Myth of FDA as Rubber Stamp

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 Stamp 2015-08-21T15:24:01+00:00

Independent Pre-FDA Draft Guidances from Stakeholders

The introduction to an FDA draft guidance for industry published in June 2015, "Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment," makes an unusual statement: Development of this guidance was preceded by the submission to FDA of a proposed draft guidance independently prepared by a consortium of stakeholders including patients, parents and caregivers, clinicians, [...]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 Stakeholders 2015-08-04T14:58:03+00:00
SUBMIT RFP