Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

Regulatory Affairs

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
See more Regulatory Affairs news

Latest Regulatory Affairs News and Insight

View all Regulatory Affairs news or find news targeted to your interests
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
View all Regulatory Affairs news or find news targeted to your interests

Buy the latest industry research online today!
Shire Plc : Pharmaceuticals & Healthcare - Company Profile, SWOT & Financial Report 03 October 2013 This report is a crucial resource for industry executives and anyone looking to access key information about "Shire Plc" The report utilizes a wide range of primary and secondary sources, which are analyzed and presented in a consistent and easily accessible format. ICD Research strictly follows a standardized research methodology to ensure high levels of data quality and these characteristics guarantee a unique report. Buy online from $250