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Trulicity | 125469 | dulaglutide | 0 | 1. Introduction | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 1. Introduction
Page: (unknown)
Text:
On September 18, 2013 Eli Lilly and Company submitted a Biologics License Application (BLA) for Trulicity under section 351 of the Public Health Service Act. The applicant is seeking to indicate Trulicity as an adjunct to diet an... | [] | [] | stop | false | null |
Trulicity | 125469 | dulaglutide | 1 | 2. Background | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 2. Background
Page: (unknown)
Text:
The drug substance in Trulicity is dulaglutide. In this memorandum, I will use Trulicity and dulaglutide interchangeably. Dulaglutide is a homodimer that consists of two identical polypeptide chains linked to each other by a disulf... | [{"exact_quote": "At the EOP2 meeting the applicant was asked to carry out a dedicated study in patients with renal impairment to adequately evaluate the risk of Trulicity in this population.", "judgment_summary": "The reviewer documents an Agency recommendation to conduct a dedicated study evaluating safety risks in p... | [
{
"exact_quote": "At the EOP2 meeting the applicant was asked to carry out a dedicated study in patients with renal impairment to adequately evaluate the risk of Trulicity in this population.",
"judgment_summary": "The reviewer documents an Agency recommendation to conduct a dedicated study evaluating safet... | stop | false | null |
Trulicity | 125469 | dulaglutide | 2 | 3. CMC/Device | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 3. CMC/Device
Page: (unknown)
Text:
The drug substance is described in the background section above. The dulaglutide drug substance is manufactured using a mammalian-cell based recombinant expression system (i.e., ) and each polypeptide chain contains an
(b) (4) (b)... | [{"exact_quote": "I concur with the conclusions reached by the product quality teams (Drs. Welch, Chi and Thomas) regarding the acceptability of the manufacturing of the drug product and drug substance.", "judgment_summary": "The reviewer agrees with the product quality team that the manufacturing processes are accepta... | [
{
"exact_quote": "I concur with the conclusions reached by the product quality teams (Drs. Welch, Chi and Thomas) regarding the acceptability of the manufacturing of the drug product and drug substance.",
"judgment_summary": "The reviewer agrees with the product quality team that the manufacturing processes... | stop | false | null |
Trulicity | 125469 | dulaglutide | 3 | 4. Nonclinical Pharmacology/Toxicology | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 4. Nonclinical Pharmacology/Toxicology
Page: (unknown)
Text:
Dr. Chong has summarized the main nonclinical toxicology findings. Dr. Hummer has reviewed nonclinical pharmacology and toxicology studies in details. The main nonclinical findings relate to the effect of d... | [{"exact_quote": "The non-clinical findings are consistent with other members of the class and the approach to labeling, risk evaluation and mitigation strategy as well as post marketing surveillance will be consistent with other members of the class.", "judgment_summary": "The reviewer recommends that labeling, REMS, ... | [{"exact_quote": "The non-clinical findings are consistent with other members of the class and the approach to labeling, risk evaluation and mitigation strategy as well as post marketing surveillance will be consistent with other members of the class.", "judgment_summary": "The reviewer recommends that labeling, REMS, ... | stop | false | null |
Trulicity | 125469 | dulaglutide | 4 | 5. Clinical Pharmacology/Biopharmaceutics | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 5. Clinical Pharmacology/Biopharmaceutics
Page: (unknown)
Text:
I concur with the conclusions reached by the clinical pharmacology/biopharmaceutics reviewer (Dr. Sang Chung) that there are no outstanding clinical pharmacology issues that preclude approval. Dulaglutid... | [{"exact_quote": "I concur with the conclusions reached by the clinical pharmacology/biopharmaceutics reviewer (Dr. Sang Chung) that there are no outstanding clinical pharmacology issues that preclude approval.", "judgment_summary": "The reviewer confirms that all clinical pharmacology questions have been adequately ad... | [
{
"exact_quote": "I concur with the conclusions reached by the clinical pharmacology/biopharmaceutics reviewer (Dr. Sang Chung) that there are no outstanding clinical pharmacology issues that preclude approval.",
"judgment_summary": "The reviewer confirms that all clinical pharmacology questions have been a... | stop | false | null |
Trulicity | 125469 | dulaglutide | 5 | 7. Clinical/Statistical-Efficacy | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 7. Clinical/Statistical-Efficacy
Page: (unknown)
Text:
To support the indication of improved glycemic control, the medium to long term glucose lowering effect of dulaglutide 0.75 mg and 1.5 mg was evaluated in 5 completed phase 3 clinical trials.
The pivotal trials ... | [] | [] | stop | false | null |
Trulicity | 125469 | dulaglutide | 6 | o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks
Page: (unknown)
Text:
- 1 HbA1c = Hemoglobin A1c
- 2 OAM = Oral anti-diabetic medication.
- o Compared dulaglutide 0.75 mg and 1.5 mg weekly to placebo (26 weeks) and to sitagliptin 100 mg (5... | [{"exact_quote": "Dr. McEvoy notes that the endpoint analyzed was not strictly speaking the change in HbA1c from baseline to the landmark visit but in actuality could reflect the change from baseline to either the landmark visit, the onset of rescue (for subjects rescued) or the last on study visit (for subjects who di... | [
{
"exact_quote": "Dr. McEvoy notes that the endpoint analyzed was not strictly speaking the change in HbA1c from baseline to the landmark visit but in actuality could reflect the change from baseline to either the landmark visit, the onset of rescue (for subjects rescued) or the last on study visit (for subject... | stop | false | null |
Trulicity | 125469 | dulaglutide | 7 | o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks
Page: (unknown)
Text:
I will use the dulaglutide 0.75 mg to metformin comparison to illustrate this. For this comparison, the superiority of dulaglutide 0.75 mg to metformin in HbA1c reduction ... | [{"exact_quote": "For this comparison, the superiority of dulaglutide 0.75 mg to metformin in HbA1c reduction at week 26 was not supported by the prespecified MMRM analysis or the ANCOVA model using LOCF", "judgment_summary": "The primary statistical models failed to demonstrate statistically significant superiority of... | [
{
"exact_quote": "For this comparison, the superiority of dulaglutide 0.75 mg to metformin in HbA1c reduction at week 26 was not supported by the prespecified MMRM analysis or the ANCOVA model using LOCF",
"judgment_summary": "The primary statistical models failed to demonstrate statistically significant su... | stop | false | null |
Trulicity | 125469 | dulaglutide | 8 | o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks
Page: (unknown)
Text:
similar intensity of insulin titration (e.g., in the ORIGIN trial for example 50% of enrollees were within FPG goal of 95... | [{"exact_quote": "Achievement of titration goal is likely to be dependent on the adequacy of trial monitoring and on the willingness and motivation of investigators and participants to follow protocol mandated titration algorithms", "judgment_summary": "The reviewer suggests that insufficient monitoring or participant/... | [
{
"exact_quote": "Achievement of titration goal is likely to be dependent on the adequacy of trial monitoring and on the willingness and motivation of investigators and participants to follow protocol mandated titration algorithms",
"judgment_summary": "The reviewer suggests that insufficient monitoring or ... | stop | false | null |
Trulicity | 125469 | dulaglutide | 9 | o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks
Page: (unknown)
Text:
8. Safety
Drs. Chong and Balakrishnan have summarized the general safety findings in the application and Dr. Charles the cardiovascular risk analyses specifically. Three ... | [{"exact_quote": "Deaths and serious adverse events were balanced and Dr. Balakrishnan did not note an imbalance for one particular type of serious adverse event.", "judgment_summary": "The reviewer found no imbalance in mortality or serious adverse events across treatment groups.", "statement_type": "positive_assessme... | [{"exact_quote": "Deaths and serious adverse events were balanced and Dr. Balakrishnan did not note an imbalance for one particular type of serious adverse event.", "judgment_summary": "The reviewer found no imbalance in mortality or serious adverse events across treatment groups.", "statement_type": "positive_assessme... | stop | false | null |
Trulicity | 125469 | dulaglutide | 10 | o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks
Page: (unknown)
Text:
Elements identified in the review that suggest a causal link between dulaglutide and; injection site, hypersensitivity, gastro-intestinal, and arrhythmia related adverse r... | [{"exact_quote": "Elements identified in the review that suggest a causal link between dulaglutide and; injection site, hypersensitivity, gastro-intestinal, and arrhythmia related adverse reactions as well as increases in amylase and lipase levels 3-fold above the upper limit of normal included; a close temporal associ... | [
{
"exact_quote": "Elements identified in the review that suggest a causal link between dulaglutide and; injection site, hypersensitivity, gastro-intestinal, and arrhythmia related adverse reactions as well as increases in amylase and lipase levels 3-fold above the upper limit of normal included; a close tempora... | stop | false | null |
Trulicity | 125469 | dulaglutide | 11 | o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: o Double Blind H9X-MC-GBDF- Efficacy assessments at 26 weeks and 52 weeks
Page: (unknown)
Text:
Cardiovascular risk
To meet the requirements outlined in the Guidance to Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Tre... | [{"exact_quote": "The results of this analysis do not suggest that dulaglutide-use is associated with excess CV-risk, as defined in the Guidance, compared to a pool of comparators in the population studied in the Phase 2 and 3 program (relatively low risk population).", "judgment_summary": "The reviewer concludes that ... | [{"exact_quote": "The results of this analysis do not suggest that dulaglutide-use is associated with excess CV-risk, as defined in the Guidance, compared to a pool of comparators in the population studied in the Phase 2 and 3 program (relatively low risk population).", "judgment_summary": "The reviewer concludes that ... | stop | false | null |
Trulicity | 125469 | dulaglutide | 12 | 9. Advisory Committee Meeting | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 9. Advisory Committee Meeting
Page: (unknown)
Text:
Dulaglutide is the fifth member of the GLP-1 agonist class of anti-diabetic drugs. No new efficacy or safety issue identified in the application rose to the level of requiring the input from an advisory panel. There... | [] | [] | stop | false | null |
Trulicity | 125469 | dulaglutide | 13 | 12. Decision/Action/Risk Benefit Assessment | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 12. Decision/Action/Risk Benefit Assessment
Page: (unknown)
Text:
- Regulatory Action Approval
- Risk Benefit Assessment Benefits Assessment: The applicant has demonstrated in two adequate and well controlled trials that dulaglutide 0.75 and 1.5 mg administered s... | [{"exact_quote": "statistical, design and conduct issues were identified and are summarized in the efficacy section of this memorandum.", "judgment_summary": "The reviewer identifies statistical, design, and conduct issues in the trials that are detailed elsewhere in the review.", "statement_type": "explicit_concern", ... | [
{
"exact_quote": "statistical, design and conduct issues were identified and are summarized in the efficacy section of this memorandum.",
"judgment_summary": "The reviewer identifies statistical, design, and conduct issues in the trials that are detailed elsewhere in the review.",
"statement_type": "exp... | stop | false | null |
Trulicity | 125469 | dulaglutide | 14 | 12. Decision/Action/Risk Benefit Assessment | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Trulicity Summary Review
Section heading: 12. Decision/Action/Risk Benefit Assessment
Page: (unknown)
Text:
Recommendation for Postmarketing Risk Evaluation and Mitigation Strategies
Dulaglutide will be approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan ... | [{"exact_quote": "Dulaglutide will be approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks of thyroid C-cell tumors and pancreatitis.", "judgment_summary": "The reviewer recommends a REMS communication plan due to ... | [
{
"exact_quote": "Dulaglutide will be approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks of thyroid C-cell tumors and pancreatitis.",
"judgment_summary": "The reviewer recommends a REMS communication ... | stop | false | null |
Ofev | 205832 | nintedanib | 0 | 205832Orig1s000 | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 205832Orig1s000
Page: (unknown)
Text:
SUMMARY REVIEW
SUMMARY REVIEW OF REGULATORY ACTION Date: October 10, 2014 From: Badrul A. Chowdhury, MD, PhD
Director, Division of Pulmonary, Allergy and Rheumatology Products, CDER, FDA
Subject: Division Director Summary Review ND... | [] | [] | stop | false | null |
Ofev | 205832 | nintedanib | 1 | 1. Introduction | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 1. Introduction
Page: (unknown)
Text:
Boehringer Ingelheim Pharmaceuticals, Inc. (BI) submitted this 505(b)(1) application for use of nintedanib 150 mg and 100 mg capsules for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The proposed dose is 150 mg ... | [] | [] | stop | false | null |
Ofev | 205832 | nintedanib | 2 | 2. Background | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 2. Background
Page: (unknown)
Text:
IPF is a diffuse progressive parenchymal lung disease of unknown etiology, characterized by fibrotic interstitial infiltrates that are consistent with the histopathologic pattern of usual interstitial pneumonia.1 It is the most common t... | [] | [] | stop | false | null |
Ofev | 205832 | nintedanib | 3 | 2. Background | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 2. Background
Page: (unknown)
Text:
Pertinent regulatory interactions between BI and the Agency include a Pre-IND Meeting in August 2006, End-of-Phase 2 (EOP2) Meeting in December 2010, and a Pre-NDA meeting in October 2013. At the Pre-IND meeting the Division informed BI... | [{"exact_quote": "At the Pre-IND meeting the Division informed BI that there was a lack of non-clinical support for dosing in IPF patients.", "judgment_summary": "The Division identified insufficient non-clinical data to justify the proposed dosing regimen for IPF patients.", "statement_type": "explicit_concern", "topi... | [
{
"exact_quote": "At the Pre-IND meeting the Division informed BI that there was a lack of non-clinical support for dosing in IPF patients.",
"judgment_summary": "The Division identified insufficient non-clinical data to justify the proposed dosing regimen for IPF patients.",
"statement_type": "explicit... | stop | false | null |
Ofev | 205832 | nintedanib | 4 | 2. Background | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 2. Background
Page: (unknown)
Text:
(b) (4)
(b) (4)
The packaging will be performed at the BI Pharma site in Germany. All manufacturing and testing facilities associated with this application have acceptable inspection status. The various DMFs associated with the manufa... | [] | [] | stop | false | null |
Ofev | 205832 | nintedanib | 5 | 4. Nonclinical Pharmacology and Toxicology | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 4. Nonclinical Pharmacology and Toxicology
Page: (unknown)
Text:
BI submitted a complete toxicology program that included general toxicology studies in mice, rats, and monkeys for up to 12 months; reproductive and developmental toxicology studies in rats and rabbits; and ... | [{"exact_quote": "The only observation in monkeys at the low dose of 10 mg/kg/day was growth plate thickening, which is unlikely to be relevant to an older adult population.", "judgment_summary": "The reviewer concludes that the observed growth plate thickening in monkeys at low doses is not clinically relevant to the ... | [
{
"exact_quote": "The only observation in monkeys at the low dose of 10 mg/kg/day was growth plate thickening, which is unlikely to be relevant to an older adult population.",
"judgment_summary": "The reviewer concludes that the observed growth plate thickening in monkeys at low doses is not clinically rele... | stop | false | null |
Ofev | 205832 | nintedanib | 6 | 5. Clinical Pharmacology and Biopharmaceutics | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 5. Clinical Pharmacology and Biopharmaceutics
Page: (unknown)
Text:
BI submitted a complete and adequate clinical pharmacology program for nintedanib. Nintedanib will be recommended for administration with food, as coadministration with food increased exposure (AUC and Cm... | [{"exact_quote": "Nintedanib will be recommended for administration with food, as coadministration with food increased exposure (AUC and Cmax by 20%).", "judgment_summary": "The reviewer recommends that the product be administered with food due to a clinically relevant increase in systemic exposure.", "statement_type":... | [
{
"exact_quote": "Nintedanib will be recommended for administration with food, as coadministration with food increased exposure (AUC and Cmax by 20%).",
"judgment_summary": "The reviewer recommends that the product be administered with food due to a clinically relevant increase in systemic exposure.",
"... | stop | false | null |
Ofev | 205832 | nintedanib | 7 | 7. Clinical and Statistical – Efficacy | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 7. Clinical and Statistical – Efficacy
Page: (unknown)
Text:
a. Overview of the clinical program Some characteristics of the relevant clinical studies that form the basis of review and regulatory decision for this application are shown in Table 1. The design and conduct o... | [] | [] | stop | false | null |
Ofev | 205832 | nintedanib | 8 | 7. Clinical and Statistical – Efficacy | null | You are assisting a regulatory science research project that studies how FDA reviewers express judgment in drug review documents (Summary Reviews, Medical, Statistical, Clinical Pharmacology, and Product Quality reviews).
Your task: read a section of an FDA review document and extract every REVIEWER-IDENTIFIED CONCERN... | Document: Ofev Summary Review
Section heading: 7. Clinical and Statistical – Efficacy
Page: (unknown)
Text:
- b. Design and conduct of the studies
Studies 30, 32, and 34 were similar in design and conduct except for the treatment arms as noted in Table 1. All three studies were randomized, double-blind, placebo-cont... | [{"exact_quote": "Time to first IPF exacerbation was adjudicated in Studies 32 and 34, but investigator-reported only in Study 30.", "judgment_summary": "The reviewer implies that relying solely on investigator-reported exacerbations in Study 30, unlike the adjudicated approach in the other studies, may limit endpoint ... | [{"exact_quote": "Time to first IPF exacerbation was adjudicated in Studies 32 and 34, but investigator-reported only in Study 30.", "judgment_summary": "The reviewer implies that relying solely on investigator-reported exacerbations in Study 30, unlike the adjudicated approach in the other studies, may limit endpoint ... | stop | false | null |
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