Required Clinical Trial After Approval Database

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This dataset is the main file to construct the FDA (U.S. Food and Drug Administration) Postmarketing Requirements and Commitments searchable database. Postmarketing requirements refers to studies required to be conducted under statutes or regulations after product approval. Postmarketing commitments are not required studies that sponsors conduct. Official FDA’s website has an available database to provide public detailed information on postmarketing requirements and commitments studies.

Complexity

The phrase postmarketing requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product’s safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conducting. The Agency has made available a searchable database of information on postmarketing studies and clinical trials for drugs and biological products.

Postmarketing requirements (PMRs) include studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations. Postmarketing commitments (PMCs) are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation. In the past, the word commitment has been used to cover both required and not required studies and clinical trials. Now, because commitments and requirements are treated differently under the law, the terminology, that distinguishes between studies and clinical trials that are required and those that a sponsor agrees to conduct that are not required, is being used.

Commitments containing proprietary information (e.g., those to evaluate chemistry or manufacturing and control issues) are not included.

The studies and clinical trials that can be required under FDAAA (Food and Drug Administration Amendments Act) join the types of studies and clinical trials that FDA could require before FDAAA. Before FDAAA, FDA could require the following studies or clinical trials:

Postmarketing studies or clinical trials to demonstrate clinical benefit for drugs approved under the accelerated approval requirements in 21 CFR 314.510 and 21 CFR 601.41 Deferred pediatric studies (21 CFR 314.55(b) and 601.27(b)), where studies are required under the Pediatric Research Equity Act (PREA) Studies or clinical trials to demonstrate safety and efficacy in humans that must be conducted at the time of use of products approved under the Animal Efficacy Rule (21 CFR 314.610(b)(1) and 601.91(b)(1)) Now, under FDAAA, postmarketing studies and clinical trials also can be required to assess a known serious risk related to the use of the drug, assess signals of serious risk related to the use of the drug and identify an unexpected serious risk when available data indicate the potential for a serious risk

This contains information about postmarketing studies and clinical trials previously reported under the Modernization Act (both requirements and commitments), and it also contains information about studies and clinical trials required under FDAAA. Some changes have been made.

PMR refers to postmarketing requirements, studies or clinical trials the sponsor is required to conduct
PMC now refers to postmarketing commitments, studies or clinical trials to which sponsors commit but that they are not required to conduct.

Changes have been made to the searchable database of information on postmarketing studies and clinical trials for drugs and biological products.

Date Created

2016-04-30

Last Modified

2020-07-28

Version

2020-07-28

Update Frequency

Quarterly

Temporal Coverage

1946 to 2020

Spatial Coverage

United States

Source

John Snow Labs; US Food and Drug Administration;

Source License URL

Source License Requirements

N/A

Source Citation

US Food and Drug Administration, F.D.A. (2016). FDA.gov. Retrieved 5 May, 2016.

Keywords

FDA Postmarketing Requirements, FDA Postmarketing Commitments, FDA Postmarketing Studies, FDA Searchable Database, FDA Clinical Trial Regulations, FDA Clinical Trial Statuses, FDA Clinical Trials, FDAAA, PMC CMT

Other Titles

Postmarketing Requirments and Commitments Database, Post Approval Studies, Postmarketing Requirements and Commitments for Human Drugs

NameDescriptionTypeConstraints
IDPMC (Postmarketing Study Commitments) IDintegerlevel : Nominal required : 1
NumberRequirement/Commitment Number. This is the number as it appears in Agency letters.integerlevel : Nominal required : 1
Document_TypeType of PMC (Postmarketing Study Commitments) document.stringenum : Array required : 1
Document_Type_NumberPMC (Postmarketing Study Commitments) document type numberintegerlevel : Nominal required : 1
DescriptionDescription of the studystringrequired : 1
StatusCurrent status of the application; pending, ongoing, delayed, submitted, fulfilled, releasedstringenum : Array required : 1
Status_DescriptionDescription of the statusstring-
Annual_Report_Receiving_DateThe date FDA received the latest annual reportdate-
NDA_BLA_Approval_DateThe date the product was originally approved by FDAdaterequired : 1
Final_Report_Due_DateThe date the next report is due. This appears only for studies/clinical trials where this information is available.date-
NDA_NumberNew drug application numberintegerlevel : Nominal required : 1
ApplicantThe name of the applicant (e.g., a company name)stringrequired : 1
ProductThe name of the product followed by the active ingredientstringrequired : 1
Is_Public_FlagStates if certain information is available to the public.boolean-
CDER_or_CBERWhether is regulated by the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER).stringenum : Array required : 1
Subpart_FlagSub part flagstringenum : Array
IDNumberDocument TypeDocument Type NumberDescriptionStatusStatus DescriptionAnnual Report Receiving DateNDA BLA Approval DateFinal Report Due DateNDA NumberApplicantProductIs Public FlagCDER or CBERSubpart Flag
3199211N0Conduct a controlled postmarketing study to track adverse events in the recipients of Trima Accel collected platelets stored in 65% Isoplate/ 35% plasma. Adverse events (e.g., transfusion reactions) will be captured through active surveillance of the test and the control products (platelets stored in plasma). Transfusion reactions will be classified and compared by type (e.g., TRALI, febrile non-hemolytic transfusion reaction, allergic reaction, etc.).S2018-05-162013-03-0590067TERUMO BCTIsoplate Solution, unidentifiable productTrueCBF
3199221S5597Grifols commits to performing a pharmacokinetic (PK) study on 15-20 HAV seronegative subjects, to evaluate the likelihood that pre-exposure prophylaxis using doses of 0.2 mL/kg will provide protection to recipients for up to 60 days after injection. The study will last for 150 days. Grifols will evaluate the availability of GamaSTAN-C and, if available, will use it for the clinical study.F2018-02-081944-01-112018-11-30101134Grifols Therapeutics LLCGamaSTAN S/D; BayGam, Immune Globulin (Human)TrueCB
3199231S1033Conduct a study to evaluate the immunogenic potential of the terminal heat-treated product.DThe study completion date has passed, and the study has not yet been completed.2019-09-101978-08-152011-02-15102475Grifols Biologicals LLCAlphanate, Antihemophilic Factor/von Willebrand Factor Complex (Human)TrueCB
3199241S5002Conduct a Postmarketing study to further evaluate safety and efficacy of the product in type 3 vWD patients undergoing major surgeries.DThe study completion date has passed, and the study has not yet been completed2019-09-101978-08-152009-12-31102475Grifols Biologicals LLCAlphanate, Antihemophilic Factor/von Willebrand Factor Complex (Human)TrueCB
3199251S5520Conduct two clinical trials: Trial 1: A pilot study of the safety and pharmacokinetics of Prolastin-C administered weekly at a dose of 120 mg/kg. Trial 2: An adequately-powered study of clinically meaningful endpoints -Prolastin-C efficacy study using CT scans as the primary endpoint.O2020-01-161987-12-022028-05-18103174Grifols Therapeutics LLCProlastin; Prolastin-C, Alpha-1-Proteinase Inhibitor (Human)TrueCB
3199261S5344Final Protocol Submission: November 30, 2016 Study/Trial Completion: To be determined should an event occur. Final Report Submission: To be determined should an event occur.P1998-11-12103821Emergent BioDefense Operations Lansing LLCBioThrax, Anthrax Vaccine AdsorbedTrueCBE
3199271S5574Establish a pregnancy registry that will enroll women exposed to Fluzone Quadrivalent during pregnancy and collect data on their outcomes and newborn health status.O2019-08-261999-12-092020-12-31103914Sanofi Pasteur Inc.Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent; Fluzone HD Quadrivalent, Influenza Virus VaccineTrueCB
3199281S5733To establish a pregnancy registry that will enroll women exposed to Fluzone Intradermal Quadrivalent during pregnancy and collect data on their outcomes and newborn health status. Annual reports for this registry will be submitted with the Periodic Benefit-Risk Evaluation Report that includes all other FluzoneĀ® influenza vaccines. When the registry has collected data on the outcomes specified in the protocol for 4 years, Sanofi will submit a final study report including information for both Fluzone Intradermal Quadrivalent and Fluzone Quadrivalent vaccine (administered intramuscularly). After submission of the registry report, Sanofi will continue enrolling in the registry pending CBER review of the report and determination that the registry can be discontinued.S2019-08-261999-12-092020-12-31103914Sanofi Pasteur Inc.Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent; Fluzone HD Quadrivalent, Influenza Virus VaccineTrueCB
3199291S6290Study is ongoing.OStudy is ongoing.2019-08-261999-12-092021-04-30103914Sanofi Pasteur Inc.Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent; Fluzone HD Quadrivalent, Influenza Virus VaccineTrueCBP
3199302S6290Deferred pediatric study QHD00014 under PREA to evaluate the safety and effectiveness of Fluzone High Dose Quadrivalent, for the prevention of influenza disease caused by influenza subtype A viruses and type B viruses contained in the vaccine in pediatric patients ages 6 months to less than 3 years of age.PThe study has not been initiated, but does not meet the criterion for delayed.2019-08-261999-12-092025-06-30103914Sanofi Pasteur Inc.Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent; Fluzone HD Quadrivalent, Influenza Virus VaccineTrueCBP