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Regulatory Affairs
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NSF International: Coping With Brutal Disruption - Six Simple Rules
In a world of ever-increasing and sometimes unpredictable change, it has never been more important for pharmaceutical companies to bounce back stronger from such “brutal disruptions.”
Regulatory Affairs > Press Releases
FDA grants priority review to Pfizer's antibody-drug conjugate for ALL
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a priority review designation to Pfizer's anti-CD22 antibody-drug conjugate inotuzumab ozogamicin to treat patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
European Commission conditionally approves Roche’s cancer drug Alecensa
By PBR Staff Writer
Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib.
Regulatory Affairs > News
Valeant gets FDA approval for SILIQ to treat moderate-to-severe plaque psoriasis
The US Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals International's Biologics License Application (BLA) for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
Marathon Pharmaceuticals’ Duchenne muscular dystrophy drug wins FDA approval
By PBR Staff Writer
Marathon Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Emflaza (deflazacort) to treat Duchenne muscular dystrophy in patients 5 years and older.
Regulatory Affairs > News
Amgen secures FDA approval for Parsabiv drug to treat chronic kidney disease
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) undergoing hemodialysis.
Regulatory Affairs > News
NSF International and IDMA Offer Pharmaceutical Quality Management Education in Bangalore
Advanced Program in Pharmaceutical Quality Management leads to an international certification in pharmaceutical GMP compliance from NSF International and Indian Drug Manufacturers’ Association
Regulatory Affairs > Press Releases
Sobi secures European Commission approval for new dosing frequency of Orfadin
The European Commission (EC) has approved a reduced dosing frequency for Swedish Orphan Biovitrum International's (Sobi) Orfadin (nitisinone) from twice daily to once daily, in people with hereditary tyrosinemia type 1 (HT-1) with a body weight >20 kg.
Regulatory Affairs > News
FDA approves Sanofi's Xyzal Allergy 24HR for OTC use
By PBR Staff Writer
Sanofi has secured approval from the US Food and Drug Administration (FDA) for its 24-hour formulation of levocetirizine dihydrochloride (Xyzal Allergy 24HR) for the over-the-counter (OTC) treatment of symptoms associated with seasonal and year-round allergies.
Regulatory Affairs > News
EU approves Novartis’ Votubia to treat seizures in TSC patients
By PBR Staff Writer
The European Commission (EC) has expanded the approved uses of Novartis' drug Votubia (everolimus) to include treatment for refractory partial-onset seizures in patients with tuberous sclerosis complex (TSC).
Regulatory Affairs > News
FDA approves label update to Allergan's Avycaz
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA)for Avycaz to include new phase III data in patients with complicated urinary tract infections (cUTI), including Pyelonephritis.
Regulatory Affairs > News
FDA approves 72 mcg dose of LINZESS for adults with chronic idiopathic constipation
The US Food and Drug Administration (FDA) has approved a 72 mcg dose of Ironwood Pharmaceuticals' LINZESS(linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients.
Regulatory Affairs > News
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
FDA approves Imbruvica for relapsed/refractory marginal zone lymphoma
The US Food and Drug Administration (FDA) has granted an accelerated approval to Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma (MZL), a rare type of Non-Hodgkin's Lymphoma.
Regulatory Affairs > News

PBR Supplier Recommendations

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
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
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

Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Regulatory Affairs > White Papers Autoinjectors From Planning to Launch By SHL Group
Injectable drug delivery devices such as pen injectors and autoinjectors show a significant growth potential in the future. This white paper focuses on the development process of an autoinjector project from planning to launch and best practices on how to prepare for and address potential challenges along the way.... Regulatory Affairs > White Papers Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems By SHL Group
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.... Regulatory Affairs > White Papers Complex Module Manufacturing – IC testing Devices By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers Specialised Project & Technology Transfer – Precision Neurosurgical Equipment By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers See more
1-15 of 3702 results