In case you are inte­res­ted, the follo­wing repre­sents Phase 3 of the FDA Trans­pa­rency Ini­tia­tive, which could end up bene­fi­ting thy­roid patients as we deal with the upco­ming cli­ni­cal trials for natu­ral desic­ca­ted thy­roid. The links at the bot­tom give more unders­tan­ding, as well.

For Imme­diate Release: March 12, 2010

FDA Task Force Seeks Public Com­ments on Inc­rea­sing Trans­pa­rency With Regu­la­ted Industry

As part of the final phase of its trans­pa­rency ini­tia­tive, the U.S. Food and Drug Admi­nis­tra­tion is see­king com­ment from the public and other inte­res­ted sta­kehol­ders on how the agency can inc­rease trans­pa­rency in its inte­rac­tions with regu­la­ted industry.

Pos­ted in the March 12, 2010, Fede­ral Regis­ter, the request for elec­tro­nic or writ­ten com­ments has a dead­line of April 12, 2010.

The FDA regu­la­tes pro­ducts res­pon­si­ble for about 25 per­cent of the gross natio­nal pro­duct of the Uni­ted Sta­tes and the indus­tries res­pon­si­ble for these pro­ducts. Pro­ducts regu­la­ted by the agency – bio­lo­gics and blood pro­ducts, human drugs, foods, medi­cal devi­ces, radiation-emitting devi­ces, and vete­ri­nary medi­ci­nes – are inte­gral to public health and to the U.S. economy.

The agency for­med an inter­nal Trans­pa­rency Task Force in res­ponse to the Obama Administration’s com­mit­ment to achieve “an unpre­ce­den­ted level of open­ness in Govern­ment.” The Task Force is deve­lo­ping recom­men­da­tions for making infor­ma­tion about FDA acti­vi­ties and deci­sions more use­ful, unders­tan­da­ble, and rea­dily avai­la­ble, while appro­pria­tely pro­tec­ting con­fi­den­tial information.

The Task Force held public mee­tings in June 2009 and Novem­ber 2009. Based upon input recei­ved thus far, the Trans­pa­rency Ini­tia­tive has been divi­ded into three pha­ses. The first phase, crea­ting a Web-based resource called “FDA Basics” to pro­vide infor­ma­tion on com­monly misun­ders­tood aspects of the agency, has been com­ple­ted. The second phase, impro­ving FDA’s disc­lo­sure of infor­ma­tion to the public, is under­way and the agency intends to issue draft pro­po­sals for public com­ment soon.

The request for com­ment for the third phase follows a series of lis­te­ning ses­sions with mem­bers of regu­la­ted industry in January 2010. Transc­ripts and sum­ma­ries of those lis­te­ning ses­sions are avai­la­ble at http://www.fda.gov/transparency and at http://www.regulations.gov.

For this final phase, the FDA is par­ti­cu­larly inte­res­ted in com­ments from all inte­res­ted par­ties on how the agency can make impro­ve­ments in the follo­wing areas:

• Trai­ning and edu­ca­tion for regu­la­ted industry about the FDA regu­la­tory pro­cess in gene­ral and/or about spe­ci­fic new requirements
• The gui­dance deve­lop­ment process
• Main­tai­ning open chan­nels of com­mu­ni­ca­tion with industry rou­ti­nely and during crises
• Pro­vi­ding use­ful and timely ans­wers to industry ques­tions about spe­ci­fic regu­la­tory issues

Elec­tro­nic com­ments may be sub­mit­ted to http://www.regulations.gov.  Sub­mit writ­ten com­ments to the Divi­sion of Doc­kets Mana­ge­ment (HFA – 305), Food and Drug Admi­nis­tra­tion, 5630 Fishers Lane, Room 1061, Rock­vi­lle, Md., 20852. All com­ments should be iden­ti­fied with doc­ket num­ber FDA – 2009 – N – 0247.

For more information:

• March 12, 2010 Fede­ral Regis­ter Notice
• FDA Trans­pa­rency Task Force Web Page
• FDA Basics Web Page
• FDA Trans­pa­rency blog: http://fdatransparencyblog.fda.gov/2010/03/final-phase-of-the-transparency-initiative-we-want-your-ideas.html
• How did we get to where we are with the FDA’s actions towards desic­ca­ted thy­roid today? Go here.