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FDA approves Purdue Pharma's Hysingla ER with abuse-deterrent properties
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Purdue Pharma's Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment.
Regulatory Affairs > News
FDA grants fast track status for Merrimack's pancreatic cancer drug MM-398
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Merrimack Pharmaceuticals' MM-398 (nanoliposomal irinotecan injection) to treat patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
Regulatory Affairs > News
Gilead's hepatitis C drug Harvoni gets marketing authorization in Europe
By PBR Staff Writer
Gilead Sciences has received marketing authorization from the European Commission for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults.
Regulatory Affairs > News
Kite Pharma gets positive opinion for orphan drug designation in Europe for cancer immunotherapy
Kite Pharma, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer, has announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL).
Regulatory Affairs > News
Genentech gets FDA approval for Avastin to treat ovarian cancer
By PBR Staff Writer
Roche's subsidiary Genentech has received approval from the US Food and Drug Adminsitartion (FDA) for its Avastin in combination with chemotherapy to treat women with platinum-resistant, recurrent ovarian cancer.
Regulatory Affairs > News
FDA approves Genzyme’s Lemtrada to treat multiple sclerosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Genzyme's Lemtrada (alemtuzumab) to treat patients with relapsing forms of multiple sclerosis (MS).
Regulatory Affairs > News
GSK seeks European approval for additional indication of eltrombopag to treat SAA
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking approval from the European Medicines Agency (EMA) for additional indication of eltrombopag (Revolade) to treat adult patients with severe aplastic anaemia (SAA), who have had an insufficient response to immunosuppressive therapy (IST).
Regulatory Affairs > News
NNIT in the Press
NNIT has more than 2,300 employees - more than 700 employees work outside the borders of Denmark – in China​​, the Czech Republic​, the ​Philippines​, Switzerland​ and in the US.
Regulatory Affairs > Press Releases
Drug Development
Transforming a compound into a drug is a massive investment. An integrated IT strategy across your clinical value chain can maximise this investment and speed up time to market.
Regulatory Affairs > Products
Quality Management
Effective quality management processes in the life science industry are critical to meet the intense regulatory requirements.NNIT can ensure you have the highest level of inspection readiness with full document compliance and validation, according to FDA and EMA requirements.
Regulatory Affairs > Products
Serialisation
Millions of people die every year due to erroneous treatment with counterfeit drugs. To break the cycle with counterfeit drugs, authorities in most major markets are putting regulations into place to enhance patient’s safety. NNIT and NNE Pharmaplan offer a full end-to-end Track and Trace programme covering all aspects of serialisation, from packaging to the point of dispense. Learn more about NNIT and find out how you comply with the serialisation requirements.
Regulatory Affairs > Products
GxP Infrastructure Outsourcing
Infrastructure complexity is increasing and life sciences companies are under a constant pressure to cut costs. Outsourcing is a lever for cutting costs and freeing up internal resources for tasks other than daily operations. NNIT deliver integrated infrastructure outsourcing and application outsourcing that can improve your business processes to reduce costs, free up resources, minimise risk and shorten time to market.
Regulatory Affairs > Products
Octapharma's Nuwiq gets Health Canada approval to treat hemophilia A
By PBR Staff Writer
Octapharma's Nuwiq has received approval from Health Canada for treatment and prophylaxis of bleeding in patients of all ages suffering with hemophilia A (congenital factor VIII deficiency).
Regulatory Affairs > News
FDA accepts to review Amgen's BLA for LDL cholesterol-lowering drug evolocumab
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Amgen's biologics license application (BLA) for an investigational fully human monoclonal antibody, evolocumab, to treat high cholesterol.
Regulatory Affairs > News
MorphoSys gets FDA fast track status for lymphoma drug MOR208
By PBR Staff Writer
MorphoSys has received fast track designation from the US Food and Drug Administration (FDA) for MOR208 to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a most common lymphoma.
Regulatory Affairs > News

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 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
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
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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
1-15 of 3188 results