FDA Launches New Web Resource for Regulated Industries

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.”

The U.S. Food and Drug Administration introduced a new Web resource on Jan. 6 called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.

The new website was launched two days after President Obama signed the Food Safety Modernization Act, which directs FDA to set up a new system of food safety oversight based on preventing problems that cause people to get sick.

The website includes basic information about the regulatory process, including information that is frequently requested by industry.

“Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health,” said FDA Commissioner Margaret Hamburg, M.D. “In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates.”

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
  • developing and executing a project to promote uniform processes and procedures across field districts

The entire list of action items contained in the report is available here.

“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,” said Joshua Sharfstein, M.D., principal deputy commissioner and 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 FDA’s website for high-priority guidance documents in development. FDA would disclose dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance.

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