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  5. FDA's Role: ClinicalTrials.gov Information
  6. Pre-Notices for Potential Noncompliance
  1. FDA's Role: ClinicalTrials.gov Information

Pre-Notices for Potential Noncompliance

FDA may issue a Preliminary Notice of Noncompliance letter (Pre-Notice) to describe potential noncompliance with certain requirements under federal law for submitting registration and/or results information to ClinicalTrials.gov. Pre-notices may be issued for potential violations relating to, for example: 

  • Failure to register an applicable clinical trial
  • Failure to submit required clinical trial information for an applicable clinical trial
  • Submission of false or misleading clinical trial information 

A Pre-Notice informs a responsible party of potential noncompliance with the legal requirements for registering and submitting results information to ClinicalTrials.gov. Pre-Notices request that the responsible party address any noncompliance within 30 days after receiving the letter. After a responsible party receives a Pre-Notice, FDA further reviews and assesses the clinical trial record as well as other relevant information to determine whether the responsible party has failed to submit required clinical trial information to the ClinicalTrials.gov data bank. If FDA determines that the responsible party failed to comply with the legal requirements, FDA will issue a Notice of Noncompliance. FDA may consider certain cases of potential noncompliance resolved without further action (e.g., when the responsible party is a defunct company), in which case FDA might decide to administratively close the matter. 

Pre-Notice of Noncompliance

The table below includes Pre-Notices issued as of March 2024. FDA intends to post Pre-Notices on a quarterly basis.

Responsible Party NCT Number(s) (if any) Pre-Notice
Aprea Therapeutics NCT03931291 01/29/2024
BeyondSpring Pharmaceuticals, Inc. NCT03931291 02/05/2024
Blaze Bioscience Inc. NCT03579602 01/29/2024
BPGbio, Inc. NCT02650804 03/21/2024
Cyclacel Pharmaceuticals, Inc. NCT00590187 02/05/2024
EpicentRx, Inc. NCT02096354 03/21/2024
GlycoMimetics Incorporated NCT02187003 01/29/2024
HiberCell NCT02981303 01/29/2024
ImaginAb, Inc. NCT03802123 03/21/2024
Imunon, Inc. NCT02112656 02/05/2024
Kodiak Sciences , Inc. NCT04049266 03/18/2024
Kura Oncology, Inc. NCT02464228 03/21/2024
Liquidia Technologies, Inc. NCT03399604 01/29/2024
Neurim Phar¬maceuticals, Ltd. NCT02615002 01/29/2024
Oscotec Inc. NCT04057118 02/13/2024
SK Life Science, Inc. NCT02535091 01/29/2024
Andrew Sloan, M.D., M.B.A. FACS NCT00752323 03/21/2024
Sol-Gel Technologies, Ltd. NCT03703310 03/21/2024
Bausch and Lomb, Incorporated NCT04140227 11/02/2023
Dana Reesman, PT, DPT NCT03606980 12/19/2023
Epizon Pharma, Inc. NCT05285787 12/06/2023
EryDel NCT02770807 12/06/2023
Jeffrey L. Neul, M.D., Ph.D. NCT03633058 12/19/2023
Mezzion Pharma Co. Ltd NCT02741115, NCT03013751 12/15/2023
Modra Pharmaceuticals NCT04028388 12/15/2023
ONY NCT03058666 11/02/2023
Ovid Therapeutics Inc. NCT03882918 12/06/2023
Denovo Biopharma LLC NCT02414165 12/05/2023
Vascular Pharmaceuticals, Inc. NCT02251067 12/15/2023
Aaron I. Vinik, M.D., Ph.D. NCT02682901 07/29/2020
Acceleron Pharma Inc. NCT01727336 07/20/2020
Accuitis Inc. NCT03064438 10/26/2020
Adamas Pharmaceuticals Inc. NCT02202551 06/09/2020
Aerpio Therapeutics NCT03197870, NCT04405245, NCT04511650 08/04/2022
Ahmed Sawas, M.D. NCT03192202 08/19/2022
AI Therapeutics Inc. NCT04446377 04/27/2023
AltruBio Inc. NCT03298022 02/27/2023
Andrew Yee, M.D. NCT04119336 06/07/2023
Applied Therapeutics, Inc. NCT04117711 07/25/2023
Aponia Laboratories Inc. NCT03852459 04/09/2021
Appili Therapeutics Inc. NCT04600895 06/20/2023
Arog Pharmaceuticals, Inc. NCT01657682 09/22/2023
Ardelyx Inc. NCT02621892, NCT02686138, NCT02727751 03/27/2020
Armata Pharmaceuticals, Inc. NCT03196219, NCT03004365, NCT03052842 06/14/2022
Asklepion Pharmaceuticals, LLC NCT02891837 07/06/2021
aTyr Pharma Inc. NCT03824392, NCT04412668 05/17/2023
AzurRx BioPharma, Inc. NCT03746483 12/22/2021
Bausch Health Americas Inc. NCT02706483 07/27/2020
Bausch and Lomb NCT01140477 07/11/2014
Baylor Research Institute NCT03193853, NCT02251431 10/18/2022
Beech Tree Labs Inc. NCT04522830 04/26/2023
BHR Pharma, LLC NCT03199963 07/19/2021
BioDelivery Sciences International NCT03009019, NCT03006276 03/25/2022
BioPharmX Inc. NCT02946788 10/27/2020
Biovie Inc. NCT03107091 02/25/2021
BioXcel Therapeutics, Inc. NCT04251910, NCT04276883, NCT05276830, and NCT04470050 07/25/2023
Botanix Pharmaceuticals NCT03573518 01/03/2022
Can-Fite BioPharma NCT02128958 07/14/2021
Celgene NCT027047734 01/12/2021
CEL-SCI Corporation NCT01265849 11/10/2021
Bei-Hung Chang, Sc.D. NCT00545623 07/11/2014
Charsire Biotechnology Corp. NCT02886494 04/29/2021
Chrono Therapeutics, Inc. NCT03178422 08/04/2022
Cincinnati Children's Hospital Medical Center NCT02778880 07/23/2020
Guy L. Clifton, M.D. NCT00178711 07/11/2014
Conatus Pharmaceuticals Inc. NCT02960204 11/12/2020
ContraFect NCT03163446 07/20/2021
CTI BioPharma Corp. NCT01321541 10/01/2020
CymaBay Therapeutics, Inc. NCT02955602, NCT03551522 12/15/2021
CytoDyn, Inc. NCT04343651, NCT02483078 06/29/2022
David Janz, M.D., M.Sc. NCT03026777 11/12/2020
David Tanen, M.D. NCT02920528 07/23/2020
Dong-A ST Co., Ltd. NCT03189563 03/07/2022
E. Steve Woodle, M.D. NCT01729494 07/22/2020
Eben Clattenburg, M.D. NCT02916927 02/28/2020
Edward A. Neuwelt, M.D. NCT00659776, NCT00659126 06/30/2023
eFFECTOR Therapeutics NCT02937675, NCT03318562, NCT03690141, NCT03616834, and NCT03258398 07/28/2023
Enterin, Inc. NCT03047629, NCT04483479, NCT03781791 04/27/2023
Epizyme Inc. NCT02860286 11/12/2020
Excellabio LLC NCT03342417 09/28/2021
FADOI Foundation NCT03045406 09/22/2023
Joseph F. Fowler, Jr., M.D. NCT00403559 11/13/2013
G1 Therapeutics, Inc. NCT02514447, NCT02978716, NCT03041311 01/07/2022
Genzyme Corporation NCT00601107 03/07/2014
Georgetown University Medical Center NCT03193437 10/18/2022
Glaukos Corporation NCT03442751 06/07/2023
GTx, Inc. NCT02368691 08/25/2020
Intra-Cellular Therapies, Inc. NCT02817906 03/12/2021
Jane H. Hsiao, Ph.D., MBA NCT03406377 02/01/2021
Jenny C. Chang, M.D. NCT01446016, NCT01931163, NCT02988986, NCT02073487 10/01/2020
The Johns Hopkins Hospital NCT00617097 03/07/2014
Kieu Hoang   11/10/2021
Light Sciences Oncology NCT02326454 02/22/2022
Lumos Pharma NCT03301636 07/15/2022
Jose Lutzky, M.D. NCT00483301, NCT00616564 03/07/2014
Maruho Co., Ltd. NCT02547441, NCT02576847 06/03/2022
Marvin R. McCreary, M.D. NCT04400890 06/29/2022
Medicure NCT01522417 03/03/2021
MicuRx Pharmaceuticals Inc. NCT03747497 03/11/2021
Multidisciplinary Association for Psychedelic Studies NCT02759185 07/27/2020
Dominique L. Musselman, M.D. NCT00166114 11/13/2013
Navidea Biopharmaceuticals NCT03938636 02/24/2023
Nicholas Breitborde, Ph.D. NCT01934972 03/05/2020
Novartis Pharmaceuticals Corporation NCT00050011 11/13/2013
NovImmune S.A. NCT01818492 06/16/2020
Nutrinia NCT02865122 10/26/2020
Ocugen NCT03785340 07/20/2021
Ocular Therapeutix Inc. NCT02914509 02/01/2021
Oklahoma Medical Research Foundation NCT02270957, NCT01781611 10/01/2020
Pacira Pharmaceuticals Inc. NCT02713178, NCT02713230, NCT02713490, NCT03015961, NCT02922592 07/27/2020
Andrey Petrikovets, M.D. NCT03052816 07/20/2020
PhaseBio Pharmaceuticals Inc. NCT02808585 03/10/2022
Polly A. Niravath, M.D. NCT02834403 10/20/2022
Presbyopia Therapies LLC NCT03201562 10/13/2020
Processa Pharmaceuticals Inc. NCT02030067 03/21/2023
Provectus Biopharmaceuticals Inc. NCT02288897 09/23/2021
RadioMedix Inc. NCT03673943 03/03/2021
Revance Therapeutics Inc. NCT04259086 05/05/2023
Romark Laboratories, L.C. NCT04359680 09/22/2023
Ryan J. Sullivan, M.D. NCT03149029 06/07/2023
Saint Luke's Health System NCT02653482 09/08/2021
Salix Pharmaceuticals, Inc. NCT00724126, NCT00731679 06/17/2014
Santen Inc. NCT03691662, NCT03691649, NCT03697811 06/07/2023
Satish K Garg, M.D. NCT03143816 07/27/2020
Kirti Saxena, M.D. NCT00622739 03/07/2014
Scynexis Inc. NCT03253094 10/20/2020
Sebela Pharmaceuticals NCT04446299, NCT04446312 09/22/2023
Secura Bio, Inc. NCT02049515, NCT02711852 11/22/2022
Selecta Biosciences, Inc. NCT02959918 03/12/2021
David P. Skoner, M.D. NCT00189436 06/17/2014
Sound Pharmaceuticals Incorporated NCT03325790 06/07/2023
Spectrum Pharmaceuticals, Inc. NCT00052442 03/07/2014
Spexis AG NCT03786094 07/25/2023
Sucampo Pharmaceuticals, Inc. NCT00595946, NCT00597428 11/13/2013
Supernus Pharmaceuticals, Inc. NCT02618434, NCT02691182, NCT03597503, NCT03638466 08/01/2023
Suzhou Kintor Pharmaceutical, Inc. NCT03899467, NCT04870606 07/07/2023
US Oncology Research NCT02000882 11/17/2021
Theodore Sunki Hong, M.D. NCT04409002 06/07/2023
Thomas S. Tooma, M.D.   03/09/2016
University Health Network, Toronto NCT02363738 03/18/2021
University of Florida NCT02287909 07/22/2020
University of Kansas Medical Center NCT04481685 08/31/2022
University of South Florida NCT02283294 07/06/2021
Urotronic, Inc. NCT03423979 05/05/2023
Validus Pharmaceuticals LLC NCT02623504 04/26/2023
Vanda Pharmaceuticals, Inc. NCT03291041 06/12/2020
Vanguard Research Group NCT02360319 09/28/2020
Viventia Bio NCT02449239 10/26/2022
Yasmin Hurd, Ph.D. NCT02539823 07/29/2020
 

 

 
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