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Bayer's BLA for Kovaltry gets FDA acceptance to treat hemophilia A
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Bayer HealthCare's biologics license application (BLA) for BAY 81-8973 (Kovaltry), a recombinant Factor VIII compound, for the treatment of hemophilia A in children and adults.
Regulatory Affairs > News
EMA committee issues positive opinion for Novartis' lung cancer drug Zykadia
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for Novartis' Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Regulatory Affairs > News
FDA approves Actavis' antibacterial drug Avycaz to treat cIAI and cUTI
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Actavis' antibacterial drug Avycaz (ceftazidime-avibactam) to treat adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI).
Regulatory Affairs > News
FDA accepts for review Teva's NDA for pain management tablets
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) for Teva Pharmaceutical's hydrocodone bitartrate extended-release (ER) tablets formulated with its abuse deterrence technology (CEP-33237) for pain management.
Regulatory Affairs > News
FDA approves Novartis's multiple myeloma drug Farydak
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Swiss drugmaker Novartis's Farydak (panobinostat) to treat patients with multiple myeloma.
Regulatory Affairs > News
Modalities
Modalities include a dedicated device, a smartphone app and IWRS.
Regulatory Affairs > Products
Respiratory Devices
Respiratory devices include: MasterScope® CT, FlowScreen® CT, AM3 ®, AM1+ ®, SpiroPro® CT and Clean Peak Flow Meter®.
Regulatory Affairs > Products
ABPM Collection Devices
ABPM collection devices include the Mortara Ambulo™ 2400.
Regulatory Affairs > Products
Holter Collection Devices
Devices include: The H12+ and CardioMem®
Regulatory Affairs > Products
ECG Collection Devices
Products include: ELI-PC 12- Lead ECG, ELI 150, ELI 10, ELI 250, MAC 1200.
Regulatory Affairs > Products
Seattle submits supplemental BLA to FDA for Phase III Aethera trial of Adcetris in HL patients
Seattle Genetics has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) based on data from Phase III Aethera trial of Adcetris (Brentuximab Vedotin) in post-transplant hodgkin lymphoma (HL) patients at high risk of relapse.
Regulatory Affairs > News
aTyr Pharma's Resolaris gets EMA orphan drug status for FSHD
By PBR Staff Writer
The European Commission (EC) has granted orphan drug designation for US-based biotherapeutics firm aTyr Pharma's investigational new drug Resolaris to treat facioscapulohumeral muscular dystrophy (FSHD).
Regulatory Affairs > News
FDA approves Celgene's Revlimid in combination with dexamethasone to treat multiple myeloma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has expanded the existing indication for Celgene's Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM).
Regulatory Affairs > News
Best Practices for Streamlining Electronic Implementation of Established COAs; Copyright January 2015
| By ERT
This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.
Regulatory Affairs > White Papers
Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study; International Journal of COPD; January 2015.
| By ERT
This paper presents the results of psychometric assessment data from a COPD eDiary developed by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.
Regulatory Affairs > White Papers

PBR Supplier Recommendations

ERT - Getting it done. Right.
ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.... Regulatory Affairs > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Regulatory Affairs > Suppliers
SHL Technologies - Contract Development and Manufacturing
SHL Technologies is a Contract Development and Manufacturing Organisation (CDMO) that provides OEM and ODM services for various industrial sectors from electronics to healthcare and medical.... Regulatory Affairs > Suppliers
NNIT - The Full Service IT Consultancy Dedicated to Life Sciences
NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. ... Regulatory Affairs > Suppliers
7PSolutions - Climate Control Solutions
7PSolutions™ was founded in 2010 to fulfill an unmet need in the life sciences and transportation industries: a single solution for climate control, security and quality management through every stage of the supply chain. ... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

Best Practices for Streamlining Electronic Implementation of Established COAs; Copyright January 2015 By ERT
This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.... Regulatory Affairs > White Papers Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study; International Journal of COPD; January 2015. By ERT
This paper presents the results of psychometric assessment data from a COPD eDiary developed by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.... Regulatory Affairs > White Papers The Use of Ambulatory Blood Pressure Monitoring in Drug Development; Copyright, January 2015 By ERT
This white paper delves into the basics of blood pressure, along with the well-documented limitations of standard and digital office blood pressure measurements. It reviews ABPM device functionality, common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.... Regulatory Affairs > White Papers The Use of Continuous ECG Recordings (Holters) in Drug Development; Copyright, December 2014 By ERT
Continuous 12 lead ECG recorders, often referred to as Holter devices, offer specific advantages to be considered over the standard 12 lead ECGs often collected during clinical trials for cardiac safety. This white paper explores the history of Holters, how sponsors, sites, and patients use these devices, and the benefits of continuous ECG recordings.... Regulatory Affairs > White Papers Predictive Value of Baseline electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Clinical Research; Innovations in Clinical Neuroscience; November 2014 By ERT
This meta-analysis examined the ability of baseline eC-SSRS lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. The review of over 74,000 eC-SSRS assessments determined that increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation.... Regulatory Affairs > White Papers See more
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