FDA unveils business resource site to bolster transparency
The FDA has launched a new webpage, FDA Basics for Industry, as part of the agency's 19-prong Transparency Initiative.
The FDA's Transparency Initiative was launched in June 2009 as one of 19 "action items" listed in the agency's FDA Transparency Initiative: Improving Transparency to Regulated Industry report, which the FDA indicated was a response to President Obama's "commitment to openness in government." The new website focuses on the transparency in the FDA in relation to businesses that the agency regulates, providing them with information about the regulatory process, standards and expectations.
"Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health," said FDA Commissioner Margaret Hamburg, MD. "In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates."
The agency has also created the FDA Basics website as well as FDA-TRACK, which publicly displays monthly performance metrics for more than 100 agency offices. Other programs planned under the Transparency Initiative include setting standards for the agency's responsiveness to email queries, expanded meeting presentations and developing a project to promote uniform processes and procedures across field districts.
The FDA promoted that its new Basics for Industry site is intended to save businesses time and resources in their interactions with the agency. The public has 60 days to comment on the FDA's draft proposals to improve transparency.
To view the new site, click here.
The FDA's Transparency Initiative was launched in June 2009 as one of 19 "action items" listed in the agency's FDA Transparency Initiative: Improving Transparency to Regulated Industry report, which the FDA indicated was a response to President Obama's "commitment to openness in government." The new website focuses on the transparency in the FDA in relation to businesses that the agency regulates, providing them with information about the regulatory process, standards and expectations.
"Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health," said FDA Commissioner Margaret Hamburg, MD. "In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates."
The agency has also created the FDA Basics website as well as FDA-TRACK, which publicly displays monthly performance metrics for more than 100 agency offices. Other programs planned under the Transparency Initiative include setting standards for the agency's responsiveness to email queries, expanded meeting presentations and developing a project to promote uniform processes and procedures across field districts.
The FDA promoted that its new Basics for Industry site is intended to save businesses time and resources in their interactions with the agency. The public has 60 days to comment on the FDA's draft proposals to improve transparency.
To view the new site, click here.