Opinion: Hiding in plain sight: The FDA’s approach to disclosing new drug applications is a disservice to public health
By disclosing new drug applications and both approval and rejection letters, @US_FDA would provide benefits to the public and industry as a whole rather than protecting the interests of the…
by Peter G. Lurie
Jun 04, 2019
3 minutes
Remember in high school when a friend told you a secret and you guarded it assiduously, only to find out that most of your classmates were already in on it? That’s a fair description of the secrecy surrounding elements of the Food and Drug Administration’s drug approval process.
As several of my former FDA colleagues and I describe in a report published Monday , it’s an open secret when a company files a
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