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FDA approves XTANDI to treat metastatic castration-resistant prostate cancer
By PBR Staff Writer
Diplomat has announced that the US Food and Drug Administration (FDA) has approved XTANDI to treat metastatic castration-resistant prostate cancer (CRPC).
Regulatory Affairs > News
SHL to Introduce Product Case Studies at the 2014 PDA Conference
Taking an advanced injection device from concept to reality requires careful planning, key design and manufacturing competencies and a thorough understanding of end-user needs. While challenges are often encountered when it comes to product development, it is the ability to overcome them in a timely manner and in a way that further improves the device project that is even more valuable.
Regulatory Affairs > Press Releases
EMA validates the marketing authorization for lung cancer drug nivolumab
By PBR Staff Writer
The European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) for Bristol-Myers Squibb' nivolumab to treat non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
Bristol-Myers Squibb announces multiple regulatory milestones for Opdivo in US and EU
Bristol-Myers Squibb Company announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union.
Regulatory Affairs > News
Rexahn's RX-3117 gets FDA orphan drug status for pancreatic cancer treatment
By PBR Staff Writer
US-based Rexahn Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its RX-3117, a new small molecule anti-metabolite, to treat patients with pancreatic cancer.
Regulatory Affairs > News
Gilead files NDA for fixed-dose combination of edipasvir/Sofosbuvir in Japan
By PBR Staff Writer
Gilead Sciences has submitted a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) seeking approval for an investigational once-daily fixed-dose combination (FDC) of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg to treat chronic genotype 1 hepatitis C virus (HCV) infection in adults.
Regulatory Affairs > News
NOXXON gets FDA orphan drug status for olaptesed pegol to treat glioblastoma
By PBR Staff Writer
NOXXON Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for one of its Spiegelmer therapeutics, olaptesed pegol (NOX-A12), indicated to treat glioblastoma in conjunction with radiotherapy.
Regulatory Affairs > News
FDA approves Galmed's request for fast track status of aramchol
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Israel-based Galmed Pharmaceuticals' request for fast track designation of its product candidate, aramchol, indicated to treat Non-Alcoholic Steato-Hepatitis (NASH), a chronic disease.
Regulatory Affairs > News
FDA grants fast track status to MedImmune's MEDI3902 for prevention of P. aeruginosa
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to MedImmune's investigational monoclonal antibody (mAb) MEDI3902 to prevent nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa).
Regulatory Affairs > News
Celgene's Otezla psoriasis drug obtains FDA approval
By PBR Staff Writer
US-based biotechnology firm Celgene has received approval from the US Food and Drug Administration (FDA) for its oral, selective inhibitor of phosphodiesterase 4 (PDE4) Otezla (apremilast) to treat patients with moderate to severe plaque psoriasis.
Regulatory Affairs > News
Amgen files BLA for investigational BiTE immunotherapy blinatumomab to treat leukemia
By PBR Staff Writer
Amgen has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab.
Regulatory Affairs > News
Japan approves Bayer's Eylea to treat myopic choroidal neovascularization
By PBR Staff Writer
Japan' Ministry of Health, Labour and Welfare (MHLW) has approved Bayer HealthCare's Eylea (aflibercept solution for injection) to treat myopic choroidal neovascularization (myopic CNV).
Regulatory Affairs > News
Lilly's Trulicity type 2 diabetes drug gets FDA approval
By PBR Staff Writer
Eli Lilly and Company has received approval from the US Food and Drug Administration for Trulicity (dulaglutide) as a treatment option for adults with type 2 diabetes.
Regulatory Affairs > News
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
Manuel Zahn to Attend GMP-BERATER Tage 2014
Manuel Zahn, founder and managing director of 3R Pharma Consulting will attend the GMP-BERATER Tage 2014. The meeting will see a small group of GMP experts meet and discuss new GMP regulations and will share their experiences at Schloss Reinach, near Freiburg, Germany, 8-9 October 2014.
Regulatory Affairs > Press Releases

PBR Supplier Recommendations

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 Group - Designer, Developer & Supplier of Auto Injectors & Pen Injectors
SHL (Scandinavian Health Ltd.) is the world's largest privately-owned designer, developer and supplier of advanced drug delivery devices.... Regulatory Affairs > Suppliers
INFOTEHNA Group - Pharmaceutical Software Solutions
INFOTEHNA Group is a leading provider of software solutions for the life sciences industries. We develop and deliver integral enterprise content, process management and regulatory compliance.... 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
TOPRA - Healthcare Regulatory Affairs
TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector.... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

NSF Health Sciences Journal – Summer 2014: What is the Biggest Risk Facing Your Company? By NSF Health Sciences Pharma Biotech PBR
At NSF Health Sciences our objective is to help you do the basics to PhD level and to help you to deliver high quality medicines on time in full. Our education courses described on page 22-27 are designed to help you excel at doing the basics and change behaviours in the workplace. The articles in this edition of the Journal are designed to do the same. Simple, readable, provocative and informative. ... Regulatory Affairs > White Papers 2014: What Will YOU Change? By NSF Health Sciences Pharma Biotech PBR
As one year closes and another one beckons it’s a time for reflection, looking back as well as forward. How did you do in 2013, and what does 2014 and beyond look like? For many, 2013 has been a real rollercoaster on the business and compliance front.... Regulatory Affairs > White Papers Human Error: Causes and Prevention By NSF Health Sciences Pharma Biotech PBR
As a leading consultancy and training provider to the pharma, biotech and devices industries, we are privileged to work with people who are both motivated and smart. In fact, our industries employ more PhDs and graduates than many other sectors! Yet, when you read through some recent 483s, you are left wondering why respected organisations, staffed with intelligent people, do some very illogical things.... Regulatory Affairs > White Papers How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11 By Vaisala pbr
This white paper outlines how Vaisala’s Continuous Monitoring System helps to meet the requirements of Title 21 CFR Part 11 and EU GMP Annex 11 as they apply to environmental monitoring and validation.... Regulatory Affairs > White Papers GMP Warehouse Mapping - Step-by-Step Guidelines for Validating Life Science Storage Facilities By Vaisala pbr
This step-by-step paper describes how to map a warehouse to comply with internationally recognized GMPs and regulatory requirements.... Regulatory Affairs > White Papers See more
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