What are the consequences of not disclosing clinical trial results? The FDA finalized the final regulations.

The FDA recently released guidelines for imposing civil fines of up to $100,000 a day for reporting violations in clinical trial databases.
in accordance with relevant federal regulations, those responsible for registering clinical trials on the official website of ClinicalTrials.gov should accurately and completely disclose the results of relevant clinical trials. The final version of the
Guidelines describes how the relevant FDA centers identify whether the responsible party has not submitted the required clinical trial registrations or results to the ClinicalTrials.gov database, or whether the responsible party has falsified data or misleading information, or failed to submit a certificate to the FDA.
the guidelines, evidence obtained from the FDA's Bioresearch Monitoring Program (BIMO) will serve as a basis for identifying and determining violations, in addition to complaints.
If the responsible party for a clinical trial may not comply with the requirements for clinical trial registration and submission of results, or violate the certification requirements set out in the Food and Drug Administration Amendment Act 2007, FDAAA, the FDA's center will first issue a pre-notice letter giving the responsible party 30 days to resolve the violation.
the FDA will review responses to advance notices, as well as clinical trial databases and other information requested or submitted by the FDA.
if a violation is found after the relevant investigation, the responsible party will receive a non-compliance notice to initiate another 30-day countdown clock for the responsible party.
notices will be posted on the FDA website.
guidelines say the penalty will depend on whether the responsible party takes corrective action within 30 days of receiving the notice of the breach.
if no action is taken, "a civil fine is resorted to, taking into account the type of violation and the lack of corrective remedies."
" guide also details the procedures the FDA will follow for civil penalty litigation under 21 CFR 17.
Under section 303 (F) (3) (A) of the Food, Drug and Cosmetic Act, the statutory minimum penalty for all violations awarded in one action does not exceed $100,000;
Factors that the FDA will consider in determining the amount of penalties include: "the nature, circumstances, scope and severity of the violation, the offender's ability to pay, the impact on the ability to continue operating, the history of such violations, the extent of the violations, and other matters required by the administration of justice."
September 2018, the FDA issued draft guidelines on how FDA centers should deal with those responsible for not truthfully disclosing the results of relevant clinical trials, as required by federal regulations.
nearly two years since the draft guide was published, it has been "smelling stairs and not coming down."
publication of the final version of the guidelines will help improve transparency in the disclosure of clinical trial results, help the industry learn from them, avoid detours, improve yield rates and ultimately benefit patients.
References: . . . . . . . . . . . . . . . . . . Bioresearch Monitoring Program (BIMO). Sept 21, 2020. Retrieved Aug 14, 2020 from 110th Congress. Food and Drug Administration Amendments Act of 2007. Sept 27, 2007. Retrieved Aug 14, 2020 from 21 CFR Part 17 - CIVIL MONEY PENALTIES HEARINGS. Retrieve Aug 14, 2020 from HHS, FDA, OGCP, CDER, CBER, CDRH, ORA. Civil Money Penalties Relating ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Some Applications and Submissions to FDA, and FDA Staff. Aug, 2020. Retrieved Aug 14, 2020 from Kari Oakes. Penalty policy for trial reporting violations finalized. Aug 14, 2020. Retrieved Aug 15, 2020 from the public number of WeChat.