The Food and Drug Administration today released 21 draft proposals that would expand the amount of information disclosed by the agency.
For lawyers, some of the most significant proposals deal with drug and medical device applications, recalls and warning letters.
One of the proposals calls for disclosing the existence of investigational applications. The FDA would also disclose whether an investigational new drug application has been placed on hold, terminated, or withdrawn.
If an unapproved drug application is withdrawn or abandoned, the FDA would provide a brief description of the product, its use, and the safety concern.
For medical devices, the FDA would also disclose when it issues a “not approvable” letter or when it seeks additional information - and the reasons why.
When a product is recalled, the FDA proposes creating a system “that provides FDA with authority to require companies to submit certain information to the agency when they initiate an action to recover or correct a product,” and that this information would be disclosed to the public “as soon as practicable.”
Also, for lower-level violations of the Federal Food, Drug, and Cosmetic Act, the FDA issues what is known as an untitled letter, notifying the person or firm of the violation and giving them an opportunity to correct it. The FDA proposes posting all untitled letters on its web site.
“We tried to strike the right balance between disclosure and confidentiality,” said Joshua Sharfstein, principal deputy commissioner and chair of the Transparency Task Force.
The proposals are open for public comment until July 20.
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