Saturday, October 24, 2015

here, some excerpts:

001. from "FDAAA 801 Requirements":

"who is responsible for registering trials and submitting results? The responsible party for a clinical trial must register the trial and submit results information. The responsible party is defined as: the sponsor of the clinical trial or the principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA's requirements for the submission of clinical trial information.  For complete statutory definitions and more information on the meaning of responsible party and sponsor, see the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial and the Responsible Party data element on [...]";

go on...

"are there penalties if I fail to register or submit results?  FDAAA 801 establishes penalties for responsible parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.  See the statutory provisions amending Civil Money Penalties and Clinical Trials Supported by Grants From Federal Agencies (PDF) for more information";


002. in "Public Law 110–85":

"this Act may be cited as the 'Food and Drug Administration Amendments Act of 2007' [...] NEW DRUGS AND DEVICES.— (A) INVESTIGATIONAL NEW DRUGS.—Section 505(i) ofthe Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))is amended in paragraph (4), by adding at the end thefollowing: ‘‘The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act.’’. (B) NEW DRUG APPLICATIONS.—Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the following: ‘‘(6) An application submitted under this subsection shall be accompanied by the certification required under section 402(j)(5)(B) of the Public Health Service Act. Such certification shall not be considered an element of such application.’’ [...] 4) CIVIL PENALTIES.—Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as amended by section 801(b), is amended by adding at the end the following: ‘‘(g)(1) With respect to a person who is a holder of an approved application under section 505 for a drug subject to section 503(b) or under section 351 of the Public Health Service Act, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period."

and densely worded so on...
Post a Comment