Pre-Notices for Potential Noncompliance
The 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, the 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 the FDA determines that the responsible party failed to comply with the legal requirements, the FDA will issue a Notice of Noncompliance. The 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 the FDA might decide to administratively close the matter.
Pre-Notice of Noncompliance
The table below includes Pre-Notices issued as of October 2024. The FDA intends to post Pre-Notices on a quarterly basis.
| Responsible Party | NCT Number(s) (if any) | Pre-Notice (YYYY-MM-DD) |
|---|---|---|
| Laurent Pharmaceuticals, Inc. | NCT03265288 | 2024-07-24 |
| Steven J. Isakoff | NCT01009788, NCT01441947 | 2024-07-24 |
| NANO MRNA Co | NCT02240238 | 2024-07-24 |
| Syros Pharmaceuticals, Inc. | NCT03512756 | 2024-08-28 |
| Senhwa Biosciences, Inc. | NCT04663737 | 2024-08-28 |
| Abionyx Pharma | NCT02697136 | 2024-08-28 |
| JCR Pharmaceuticals Co., Ltd. | NCT04227600 | 2024-08-28 |
| Glia LLC | NCT03990051 | 2024-09-13 |
| OncoNano Medicine | NCT04950166 | 2024-09-13 |
| Oncotelic Therapeutics | NCT02641639 | 2024-09-18 |
| Casi Pharmaceuticals | NCT02234986 | 2024-09-24 |
| Kristin Hudock | NCT04492514 | 2024-09-24 |
| Cogent Biosciences | NCT02401815 | 2024-09-24 |
| Amber Ophthalmics, Inc. | NCT02432807 | 2024-03-21 |
| Amylyx Pharmaceuticals Inc. | NCT03488524 | 2024-05-06 |
| Azriel Hirschfeld, M.D. | NCT01905150 | 2024-05-01 |
| Blue Earth Diagnostics | NCT04186819, NCT04186845 | 2024-06-20 |
| Cardinal Health 414, LLC | NCT02509598 | 2024-05-06 |
| Denovo Biopharma LLC | NCT03263026 | 2024-04-08 |
| Zydus Therapeutics Inc. | NCT03112681, NCT03061721, NCT03863574, NCT03639623 | 2024-06-20 |
| Aprea Therapeutics | NCT03931291 | 2024-01-29 |
| BeyondSpring Pharmaceuticals, Inc. | NCT03931291 | 2024-02-05 |
| Blaze Bioscience Inc. | NCT03579602 | 2024-01-29 |
| BPGbio, Inc. | NCT02650804 | 2024-03-21 |
| Cyclacel Pharmaceuticals, Inc. | NCT00590187 | 2024-02-05 |
| EpicentRx, Inc. | NCT02096354 | 2024-03-21 |
| GlycoMimetics Incorporated | NCT02187003 | 2024-01-29 |
| HiberCell | NCT02981303 | 2024-01-29 |
| ImaginAb, Inc. | NCT03802123 | 2024-03-21 |
| Imunon, Inc. | NCT02112656 | 2024-02-05 |
| Kodiak Sciences , Inc. | NCT04049266 | 2024-03-18 |
| Kura Oncology, Inc. | NCT02464228 | 2024-03-21 |
| Liquidia Technologies, Inc. | NCT03399604 | 2024-01-29 |
| Neurim Phar¬maceuticals, Ltd. | NCT02615002 | 2024-01-29 |
| Oscotec Inc. | NCT04057118 | 2024-02-13 |
| SK Life Science, Inc. | NCT02535091 | 2024-01-29 |
| Andrew Sloan, M.D., M.B.A. FACS | NCT00752323 | 2024-03-21 |
| Sol-Gel Technologies, Ltd. | NCT03703310 | 2024-03-21 |
| Bausch and Lomb, Incorporated | NCT04140227 | 2023-11-02 |
| Dana Reesman, PT, DPT | NCT03606980 | 2023-12-19 |
| Epizon Pharma, Inc. | NCT05285787 | 2023-12-06 |
| EryDel | NCT02770807 | 2023-12-06 |
| Jeffrey L. Neul, M.D., Ph.D. | NCT03633058 | 2023-12-19 |
| Mezzion Pharma Co. Ltd | NCT02741115, NCT03013751 | 2023-12-15 |
| Modra Pharmaceuticals | NCT04028388 | 2023-12-15 |
| ONY | NCT03058666 | 2023-11-02 |
| Ovid Therapeutics Inc. | NCT03882918 | 2023-12-06 |
| Denovo Biopharma LLC | NCT02414165 | 2023-12-05 |
| Vascular Pharmaceuticals, Inc. | NCT02251067 | 2023-12-15 |
| Aaron I. Vinik, M.D., Ph.D. | NCT02682901 | 2020-07-29 |
| Acceleron Pharma Inc. | NCT01727336 | 2020-07-20 |
| Accuitis Inc. | NCT03064438 | 2020-10-26 |
| Adamas Pharmaceuticals Inc. | NCT02202551 | 2020-06-09 |
| Aerpio Therapeutics | NCT03197870, NCT04405245, NCT04511650 | 2022-08-04 |
| Ahmed Sawas, M.D. | NCT03192202 | 2022-08-19 |
| AI Therapeutics Inc. | NCT04446377 | 2023-04-27 |
| AltruBio Inc. | NCT03298022 | 2023-02-27 |
| Andrew Yee, M.D. | NCT04119336 | 2023-06-07 |
| Applied Therapeutics, Inc. | NCT04117711 | 2023-07-25 |
| Aponia Laboratories Inc. | NCT03852459 | 2021-04-09 |
| Appili Therapeutics Inc. | NCT04600895 | 2023-06-20 |
| Arog Pharmaceuticals, Inc. | NCT01657682 | 2023-09-22 |
| Ardelyx Inc. | NCT02621892, NCT02686138, NCT02727751 | 2020-03-27 |
| Armata Pharmaceuticals, Inc. | NCT03196219, NCT03004365, NCT03052842 | 2022-06-14 |
| Asklepion Pharmaceuticals, LLC | NCT02891837 | 2021-07-06 |
| aTyr Pharma Inc. | NCT03824392, NCT04412668 | 2023-05-17 |
| AzurRx BioPharma, Inc. | NCT03746483 | 2021-12-22 |
| Bausch Health Americas Inc. | NCT02706483 | 2020-07-27 |
| Bausch and Lomb | NCT01140477 | 2014-07-11 |
| Baylor Research Institute | NCT03193853, NCT02251431 | 2022-10-18 |
| Beech Tree Labs Inc. | NCT04522830 | 2023-04-26 |
| BHR Pharma, LLC | NCT03199963 | 2021-07-19 |
| BioDelivery Sciences International | NCT03009019, NCT03006276 | 2022-03-25 |
| BioPharmX Inc. | NCT02946788 | 2020-10-27 |
| Biovie Inc. | NCT03107091 | 2021-02-25 |
| BioXcel Therapeutics, Inc. | NCT04251910, NCT04276883, NCT05276830, and NCT04470050 | 2023-07-25 |
| Botanix Pharmaceuticals | NCT03573518 | 2022-01-03 |
| Can-Fite BioPharma | NCT02128958 | 2021-07-14 |
| Celgene | NCT027047734 | 2021-01-12 |
| CEL-SCI Corporation | NCT01265849 | 2021-11-10 |
| Bei-Hung Chang, Sc.D. | NCT00545623 | 2014-07-11 |
| Charsire Biotechnology Corp. | NCT02886494 | 2021-04-29 |
| Chrono Therapeutics, Inc. | NCT03178422 | 2022-08-04 |
| Cincinnati Children's Hospital Medical Center | NCT02778880 | 2020-07-23 |
| Guy L. Clifton, M.D. | NCT00178711 | 2014-07-11 |
| Conatus Pharmaceuticals Inc. | NCT02960204 | 2020-11-12 |
| ContraFect | NCT03163446 | 2021-07-20 |
| CTI BioPharma Corp. | NCT01321541 | 2020-10-01 |
| CymaBay Therapeutics, Inc. | NCT02955602, NCT03551522 | 2021-12-15 |
| CytoDyn, Inc. | NCT04343651, NCT02483078 | 2022-06-29 |
| David Janz, M.D., M.Sc. | NCT03026777 | 2020-11-12 |
| David Tanen, M.D. | NCT02920528 | 2020-07-23 |
| Dong-A ST Co., Ltd. | NCT03189563 | 2022-03-07 |
| E. Steve Woodle, M.D. | NCT01729494 | 2020-07-22 |
| Eben Clattenburg, M.D. | NCT02916927 | 2020-02-28 |
| Edward A. Neuwelt, M.D. | NCT00659776, NCT00659126 | 2023-06-30 |
| eFFECTOR Therapeutics | NCT02937675, NCT03318562, NCT03690141, NCT03616834, and NCT03258398 | 2023-07-28 |
| Enterin, Inc. | NCT03047629, NCT04483479, NCT03781791 | 2023-04-27 |
| Epizyme Inc. | NCT02860286 | 2020-11-12 |
| Excellabio LLC | NCT03342417 | 2021-09-28 |
| FADOI Foundation | NCT03045406 | 2023-09-23 |
| Joseph F. Fowler, Jr., M.D. | NCT00403559 | 2013-11-13 |
| G1 Therapeutics, Inc. | NCT02514447, NCT02978716, NCT03041311 | 2022-01-07 |
| Genzyme Corporation | NCT00601107 | 2014-03-07 |
| Georgetown University Medical Center | NCT03193437 | 2022-10-18 |
| Glaukos Corporation | NCT03442751 | 2023-06-07 |
| GTx, Inc. | NCT02368691 | 2020-08-25 |
| Intra-Cellular Therapies, Inc. | NCT02817906 | 2021-03-12 |
| Jane H. Hsiao, Ph.D., MBA | NCT03406377 | 2021-02-01 |
| Jenny C. Chang, M.D. | NCT01446016, NCT01931163, NCT02988986, NCT02073487 | 2020-10-01 |
| The Johns Hopkins Hospital | NCT00617097 | 2014-03-07 |
| Kieu Hoang | 2021-11-10 | |
| Light Sciences Oncology | NCT02326454 | 2022-02-22 |
| Lumos Pharma | NCT03301636 | 2022-07-15 |
| Jose Lutzky, M.D. | NCT00483301, NCT00616564 | 2014-03-07 |
| Maruho Co., Ltd. | NCT02547441, NCT02576847 | 2022-06-03 |
| Marvin R. McCreary, M.D. | NCT04400890 | 2022-06-29 |
| Medicure | NCT01522417 | 2021-03-03 |
| MicuRx Pharmaceuticals Inc. | NCT03747497 | 2021-03-11 |
| Multidisciplinary Association for Psychedelic Studies | NCT02759185 | 2020-07-27 |
| Dominique L. Musselman, M.D. | NCT00166114 | 2013-11-13 |
| Navidea Biopharmaceuticals | NCT03938636 | 2023-02-24 |
| Nicholas Breitborde, Ph.D. | NCT01934972 | 2020-03-05 |
| Novartis Pharmaceuticals Corporation | NCT00050011 | 2013-11-13 |
| NovImmune S.A. | NCT01818492 | 2020-06-16 |
| Nutrinia | NCT02865122 | 2020-10-26 |
| Ocugen | NCT03785340 | 2021-07-20 |
| Ocular Therapeutix Inc. | NCT02914509 | 2021-02-01 |
| Oklahoma Medical Research Foundation | NCT02270957, NCT01781611 | 2020-10-01 |
| Pacira Pharmaceuticals Inc. | NCT02713178, NCT02713230, NCT02713490, NCT03015961, NCT02922592 | 2020-07-27 |
| Andrey Petrikovets, M.D. | NCT03052816 | 2020-07-20 |
| PhaseBio Pharmaceuticals Inc. | NCT02808585 | 2022-03-10 |
| Polly A. Niravath, M.D. | NCT02834403 | 2022-10-20 |
| Presbyopia Therapies LLC | NCT03201562 | 2020-10-13 |
| Processa Pharmaceuticals Inc. | NCT02030067 | 2023-03-21 |
| Provectus Biopharmaceuticals Inc. | NCT02288897 | 2021-09-23 |
| RadioMedix Inc. | NCT03673943 | 2021-03-03 |
| Revance Therapeutics Inc. | NCT04259086 | 2023-05-05 |
| Romark Laboratories, L.C. | NCT04359680 | 2023-09-22 |
| Ryan J. Sullivan, M.D. | NCT03149029 | 2023-06-07 |
| Saint Luke's Health System | NCT02653482 | 2021-09-08 |
| Salix Pharmaceuticals, Inc. | NCT00724126, NCT00731679 | 2014-06-17 |
| Santen Inc. | NCT03691662, NCT03691649, NCT03697811 | 2023-06-07 |
| Satish K Garg, M.D. | NCT03143816 | 2020-07-27 |
| Kirti Saxena, M.D. | NCT00622739 | 2014-03-07 |
| Scynexis Inc. | NCT03253094 | 2020-10-20 |
| Sebela Pharmaceuticals | NCT04446299, NCT04446312 | 2023-09-22 |
| Secura Bio, Inc. | NCT02049515, NCT02711852 | 2022-11-22 |
| Selecta Biosciences, Inc. | NCT02959918 | 2021-03-12 |
| David P. Skoner, M.D. | NCT00189436 | 2014-06-17 |
| Sound Pharmaceuticals Incorporated | NCT03325790 | 2023-06-07 |
| Spectrum Pharmaceuticals, Inc. | NCT00052442 | 2014-03-07 |
| Spexis AG | NCT03786094 | 2023-07-25 |
| Sucampo Pharmaceuticals, Inc. | NCT00595946, NCT00597428 | 2013-11-13 |
| Supernus Pharmaceuticals, Inc. | NCT02618434, NCT02691182, NCT03597503, NCT03638466 | 2023-08-01 |
| Suzhou Kintor Pharmaceutical, Inc. | NCT03899467, NCT04870606 | 20236-07-07 |
| US Oncology Research | NCT02000882 | 2021-11-17 |
| Theodore Sunki Hong, M.D. | NCT04409002 | 2023-06-07 |
| Thomas S. Tooma, M.D. | 2016-03-09 | |
| University Health Network, Toronto | NCT02363738 | 2021-03-18 |
| University of Florida | NCT02287909 | 2020-07-22 |
| University of Kansas Medical Center | NCT04481685 | 2022-08-31 |
| University of South Florida | NCT02283294 | 2021-07-06 |
| Urotronic, Inc. | NCT03423979 | 2023-05-05 |
| Validus Pharmaceuticals LLC | NCT02623504 | 2023-04-26 |
| Vanda Pharmaceuticals, Inc. | NCT03291041 | 2020-06-12 |
| Vanguard Research Group | NCT02360319 | 2020-09-28 |
| Viventia Bio | NCT02449239 | 2022-10-26 |
| Yasmin Hurd, Ph.D. | NCT02539823 | 2020-07-29 |