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Regulatory Affairs
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FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
Regulatory Affairs > News
FDA approves Merck’s Keytruda for cancer patients with certain biomarkers
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Regulatory Affairs > News
UK’s CMA accuses Merck of breaching competition law
The UK’s Competition and Markets Authority (CMA) has issued a statement of objections to pharmaceutical firm Merck Sharp & Dohme Limited (MSD).
Regulatory Affairs > News
NSF International's Pharma Biotech Must-Have App
NSF International, a leading provider of support services for the pharmaceutical industry, providing consulting, training, auditing, testing, remediation, quality systems and regulatory guidance on a global basis, is pleased to announce the launch of its new pharma biotech app.
Regulatory Affairs > Press Releases
NSF Regulatory Radar: 21st Century Cures Act, Promoting Innovation
The Cures Act aims to promote Drug Development Tools and Continuous Manufacturing innovations to speed up and enhance the development process of new therapeutics and reduce the failure rate by formalizing them within the regulatory framework.
Regulatory Affairs > Press Releases
Genentech’s Actemra approved by FDA for giant cell arteritis treatment
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
Regulatory Affairs > News
NSF at the 2nd PDA Europe Annual Meeting, 13-14 June, 2017, Berlin, Germany
NSF International’s pharma biotech team is proud to be attending the 2nd PDA Europe Annual Meeting, which will be held on the 13 and 14 June in Berlin.
Regulatory Affairs > Press Releases
EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Regulatory Affairs > News
FDA turns down generic version of GSK's asthma/COPD inhaler Advair Diskus
By PBR Staff Writer
Vectura and its partner Hikma Pharmaceuticals announced that the US Food and Drug Administration (FDA) turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.
Regulatory Affairs > News
Connect with SHL at Prefilled Syringe Seminar 2017 Tokyo
SHL Group is excited to announce that it will exhibit at the Prefilled Syringes Seminar 2017 Tokyo on 23-24 May, 2017.
Regulatory Affairs > Press Releases
NSF Pharma Biotech Webinar’s – Changing GMP Behaviours and the Quality Culture
View this short complimentary webinar by Martin Lush, Global Vice President of NSF Pharma Biotech and Medical Devices - Martin gives his insights on how your company can go about changing GMP behaviours and in doing so change quality culture.
Regulatory Affairs > Press Releases
Meet NSF at the Royal Pharmaceutical Society’s 15th Joint Qualified Person Symposium
NSF International’s pharma biotech team is proud to be sponsoring the Royal Pharmaceutical Society’s 15th Joint Qualified Person (QP) Symposium, which will be held on the 17th of May 2017 in London, England.
Regulatory Affairs > Press Releases
FDA approves Novartis’ Rydapt for AML and rare blood disorders
By PBR Staff Writer
Novartis’ Rydapt (midostaurin) has secured approval from the US Food and Drug Administration (FDA) in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).
Regulatory Affairs > News
Shire wins EC conditional approval for Natpar to treat hypoparathyroidism
By PBR Staff Writer
Shire has secured conditional marketing approval from the European Commission (EC) for its Natpar (rhPTH[1-84]) to treat patients with chronic hypoparathyroidism.
Regulatory Affairs > News
EC approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC
By PBR Staff Writer
AstraZeneca has secured full marketing authorization from the European Commission (EC) for its Tagrisso (osimertinib) 40mg and 80mg once-daily tablets to treat adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News

PBR Supplier Recommendations

SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Regulatory Affairs > Suppliers
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Regulatory Affairs > Suppliers
Rentschler - High-Performance Biopharmaceutical Development and Manufacturing
Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.... Regulatory Affairs > Suppliers
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
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PBR White Paper Recommendations

NSF - Site Director: KPIs Should Look Forward as well as Measure Results By NSF Health Sciences Pharma Biotech PBR
A Site Director expresses his views on how to use KPIs most productively. ... Regulatory Affairs > White Papers NSF asks a Production Director for their views on moving forward with KPIs By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics... Regulatory Affairs > White Papers NSF determines what KPIs mean for Employees By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures... Regulatory Affairs > White Papers NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.... Regulatory Affairs > White Papers Tech Talk: CHANGING GMP BEHAVIORS with NSF By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.... Regulatory Affairs > White Papers See more
1-15 of 3768 results