Institutional review board

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on: 
Thursday, April 18, 2024
Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points: 
    • See websites for contact details
      Heads of Medicines Agencies www.hma.eu
      European Medicines Agency www.ema.europa.eu

      11

      Table of contents

      12

      Abbreviations .............................................................................................. 3

      13

      Definitions ................................................................................................... 4

      14

      1.

    • redaction, masking,

      68

      hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

      69

      subject and make it identifiable.

    • 81

      Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

      82

      manufacturer provides upstream manufacturing services under contract on behalf of third-party

      83

      pharmaceutical companies.

    • 94

      Protected Personal Data (PPD): shall mean any personal data which should be protected from

      95

      disclosure.

    • ?Finalised? shall mean that the marketing

      102

      authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

    • The application of the general principles laid down in this guidance is without prejudice to

      106

      national rules on transparency.

    • The guidance should be read in conjunction with the relevant applicable

      107

      legislation and case law on transparency and data protection.

    • 117

      This guidance document is intended to apply to information/documents on medicinal products for

      118

      human use, for which the procedure has been finalised under the national, mutual recognition,

      119

      decentralised and centralised procedures.

    • Third

      124

      parties shall be informed or consulted as needed depending on respective national and European legal

      125

      frameworks.

    • 140

      In the following sections, the agreed principles on PD and CCI are presented, including guidance on

      141

      whether such information can be disclosed.

    • EMA/131365/2024

      Page 5/50

      142

      Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

      143

      to the possible disclosure of the information/documents.

    • Principles on the protection of personal data (PD)

      145

      The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.

    • In

      146

      compliance with the applicable European/national legislation, PD should be anonymised in order to

      147

      avoid the disclosure of the document undermining the privacy and integrity of any individual.

    • EMA/NCA applies a risk-based approach to assess which PD elements are to be

      152

      removed from the information/documents in order to limit the risk of re-identification.

    • are included in the MAA dossier because they have a legally

      164

      defined role or responsibility and it is in the public interest to disclose this data.

    • 168

      Applicants are advised that non-essential information (e.g., personal address, personal phone number)

      169

      should not be included in the MAA dossier.

    • The

      183

      confidentiality of records that could identify subjects should be protected, respecting the privacy and

      184

      confidentiality rules in accordance with the applicable regulatory requirement(s).

    • 185

      The applicant remains responsible for compliance with the relevant legislation in cases where such data

      186

      is inadvertently included in the MAA dossier.

    • 188

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      189

      from the information/documents in order to limit the risk of re-identification.

    • 194

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      195

      from the information/documents in order to limit the risk of re-identification.

    • 205

      Any proposal to consider information as commercially confidential should be properly justified by the

      206

      owner of the information.

    • In this respect, any reference(s) to the risk of that interest being

      209

      undermined should be foreseeable and not purely hypothetical.

    • 210

      Information that is already in the public domain is not considered to be commercially confidential.

    • Information on the Quality and Manufacturing of medicines

      226

      A general principle regarding quality and manufacturing information is that detailed information could

      227

      be considered commercially confidential but general information should be disclosed.

    • 234

      In general, and if not in the public domain, the names of manufacturers or suppliers of the active

      235

      substance or the excipients are considered commercially confidential.

    • 248

      A general description of the type of test methods used and the appropriateness of the specification is

      249

      not commercially confidential.

    • General information on the fermentation and purification process

      259

      is not commercially confidential, although details including operating parameters and specific material

      260

      requirements are commercially confidential.

    • 273

      A general description of the type of test methods used and the appropriateness of the specification is

      274

      not commercially confidential.

    • In general, the data included in clinical trial study reports is considered to be data that can be

      283

      disclosed once PD has been anonymised.

    • 338

      In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

      332
      333

      339

      (CCI) is included.

    • ?

      Direct contact details such as telephone

      Therefore, please refer to the appropriate sub-

      number, fax number, email, postal address,

      modules hereafter for guidance.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      ?

      Any quality information on the clinical batches

      principal investigator

      that might be included here (such as e.g.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      principal investigator

      Study Reports
      5.3.3.3

      as the evaluation of new formulation, innovative

      number, fax number, email, postal

      Paediatric Development Plan (PIP), etc.

    • This may include taking into

      More Than One Study
      5.3.5.4

      Other Clinical Study Reports

      5.3.6

      Reports of Post-Marketing
      Experience

      5.3.7

      Direct identifiers such as name,
      signature, contact details, etc.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

ZyVersa Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 25, 2024
Research, Diabetic nephropathy, Cholesterol, Obesity, Institutional review board, Patient, Protocol, MJFF, University, IND, IRB, Investigational New Drug, Therapy, Atherosclerosis, Metabolic syndrome, Government, Inflammasome, Pharmaceutical industry

WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.

Key Points: 
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
  • WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.
  • “Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates.
  • The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.

Aurora Spine Corporation Celebrates Second Anniversary of Initial Implantation of the World’s First Bone Density Matched DEXA-C Cervical Interbody Fusion Device

Retrieved on: 
Wednesday, March 20, 2024
ASG, ACDF, Institutional review board, MRI, Patent, Patient, United, Degenerative disc disease, DEXA, DDD, Neurosurgery, Bone density, Spine, Trial of the century, IRB

The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.

Key Points: 
  • The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.
  • I am able to confidently offer multilevel anterior fusions to patients who likely could not have benefitted from other existing implants because of their bone density.
  • In June 2023, Aurora announced that the first patient has been enrolled for its multicenter study of DEXA-CTM Cervical Interbody System.
  • Preliminarily, we have seen both in radiographs and surgical exploration that patients have incipient bone fusion by 90 days after surgery.

ZyVersa Therapeutics Announces IRB Approval of Phase 2a Clinical Trial Protocol to Evaluate Cholesterol Efflux Mediator™ VAR 200 in Patients with Diabetic Kidney Disease

Retrieved on: 
Monday, March 18, 2024
Alport syndrome, Diabetic nephropathy, VAR, Institutional review board, Lipid, Patient, Focal segmental glomerulosclerosis, Kidney disease, Fibrosis, Clinical trial, Kidney, Therapy, Chronic kidney disease, Safety, Dialysis, Cholesterol, IRB, Pharmaceutical industry

Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.

Key Points: 
  • Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.
  • WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces Institutional Review Board (IRB) approval of the Phase 2a clinical trial protocol to evaluate the efficacy and safety of Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease.
  • It is the first in human trial for VAR 200 intended to substantiate that the promising preclinical results demonstrated in three different animal models of kidney disease (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome) translate to patients with kidney disease.
  • We are excited about the potential of Cholesterol Efflux MediatorTM VAR 200 to protect against kidney injury and reduce kidney disease progression.”

Movano Health Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, April 4, 2024
Blood pressure, COVID, Institutional review board, SOC, Obesity, Growth, Remote patient monitoring, Evie, D2C, Patient, Conditional sentence, Heart rate, Sleep, Workplace, Trial of the century, Woman, TAM, Oxygen saturation (medicine), Skin temperature, Hypoxia, FDA, Hand, RPM, Food, IRB, Pharmaceutical industry

PLEASANTON, Calif., April 4, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported fourth quarter and year end 2023 results and provided a business update.

Key Points: 
  • PLEASANTON, Calif., April 4, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported fourth quarter and year end 2023 results and provided a business update.
  • Movano Health achieved significant development milestones on its path to obtaining the FDA clearances necessary to launch the medical device version of the ring, Evie Med.
  • In October 2023, announced the results of its Institutional Review Board (IRB)-approved blood pressure clinical study.
  • Management will host a conference call and live audio webcast to discuss these results and provide a business update today at 2:00 pm PT/5:00 pm ET.

BayCare Names Three to Vice President Roles; Creates New Surgical Services Vice President Position

Retrieved on: 
Thursday, February 22, 2024
Acquisition, Hospital, Eckerd College, CPH, Pathology, Physician, Microbiology, University, Growth, Public health, Lynch, Central Florida, Diversity, Institutional review board, St. Petersburg College, Inclusion, Equity, Associate, MPH, Saint Leo University, Epidemiology, Research, Environment, Public, Nursing

The health system has also created a new vice president of perioperative services position to lead surgical services initiatives across BayCare's 16 hospitals.

Key Points: 
  • The health system has also created a new vice president of perioperative services position to lead surgical services initiatives across BayCare's 16 hospitals.
  • "It is my privilege to announce the naming of three long-time BayCare team members to vice president roles," said BayCare's Chief Team Resources Officer Kyle Barr.
  • Angel Brown has been promoted to vice president of talent acquisition and inclusion.
  • BayCare has announced plans to build a 17th hospital in Manatee County, where it already has doctor's offices, and it delivers home care services across 13 counties.

BIOXCEL ALERT: Bragar Eagel & Squire, P.C. is Investigating BioXcel Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, February 10, 2024
P.C, News, FDA, Food, Therapy, Defendant, Safety, Dementia, Record, Patient, Agitation, Nursing, Telephone, Institutional review board, Pharmaceutical industry

Our investigation concerns whether the board of directors of BioXcel have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of BioXcel have breached their fiduciary duties to the company.
  • On December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease.
  • The Company announced that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.

BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

Retrieved on: 
Thursday, February 8, 2024
Heart, HF, Heart failure, Patient, FDA, IRB, Therapy, Institutional review board, Quality of life, Motivation, Pharmaceutical industry

The Company announces activation of CardiAMP HF II, a randomized controlled pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure.

Key Points: 
  • The Company announces activation of CardiAMP HF II, a randomized controlled pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure.
  • The study was approved by FDA in Q4 2023 for the treatment of ischemic etiology heart failure of reduced ejection fraction (HFrEF).
  • The data supporting the design of CardiAMP HF II is from the interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study (CardiAMP HF), a randomized, double blind, controlled study that enrolled 125 patients with New York Heart Association Class II and III ischemic heart failure.
  • The FDA approved trial size is 250 patients which has greater than 90 percent power (statistical probability of success).

Bionano Announces Publication of Interim Readout from Second Phase of Clinical Trial Analyzing Optical Genome Mapping as Standard of Care (SOC) for Prenatal Testing

Retrieved on: 
Wednesday, January 24, 2024
SAN, Standard of care, Fluorescence, University of Rochester, Test management, University, SVS, FISH, Genomics, DSM-IV codes, In situ hybridization, IRB, SOC, Karyotype, CMA, KT, Columbia University, OGM, Clinical trial, Institutional review board, Data, Diagnosis, Medical device

This publication reports on the prenatal genetic disease clinical trial program to evaluate OGM as an alternative to SOC workflows.

Key Points: 
  • This publication reports on the prenatal genetic disease clinical trial program to evaluate OGM as an alternative to SOC workflows.
  • This second interim readout is designed to evaluate endpoints connected to analytical performance using an expanded dataset in key areas of technical performance and clinical utility of OGM.
  • The study is an Institutional Review Board (IRB)-approved, multicenter, double-blinded trial with samples from 219 unique retrospective (57) and prospective (162) clinical research subjects.
  • All samples had been previously tested with traditional methods including karyotyping (KT), fluorescence in situ hybridization (FISH) and chromosomal microarray (CMA).