March 11, 2015
The FDA has introduced a new Web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that is frequently requested by industry.
As part of the agency’s ongoing transparency initiative, the site is one of the 19 action items contained in a 46-page report titled FDA Transparency Initiative: Improving Transparency to Regulated Industry. Other action items include setting an agency-wide expectation that e-mail questions to the FDA involving the regulatory process will, whenever possible, receive an answer within five business days, or a response stating when an answer can be expected; making agency presentations at key meetings widely available; and developing and executing a project to promote uniform processes and procedures across field districts.
“We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications,” remarks principal deputy commissioner Joshua Sharfstein, M.D., chairman of the agency’s Transparency Task Force.
The report also contains five draft proposals to improve FDA’s transparency to regulated industry. The draft proposals, available for public comment for 60 days, include publishing a timeline on the FDA website for high priority guidance documents in development. The FDA would disclose dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance.
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