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FDA approves Pfizer and Protalix's Elelyso to treat type 1 Gaucher Disease
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Pfizer and Protalix BioTherapeutics' Elelyso (taliglucerase alfa) for injection to treat adult and pediatric patients with confirmed diagnosis of Type 1 Gaucher disease.
Regulatory Affairs > News
Bristol-Myers's hepatitis C infection combination therapy gets European approval
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has received approval from the European Commission for Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), to treat patients with chronic hepatitis C infection (HCV).
Regulatory Affairs > News
FDA approves GlaxoSmithKline's anaemia drug Promacta
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) supplemental new drug application (sNDA) for Promacta (eltrombopag) to treat patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
Regulatory Affairs > News
EMA agrees to review Basilea’s isavuconazole marketing authorization application
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted to review Basilea Pharmaceutica’s isavuconazole marketing authorization application (MAA) for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
Regulatory Affairs > News
US DEA tightens restrictions on painkiller prescriptions
By PBR Staff Writer
The US Department of Drug Enforcement Administration (DEA) is all set to roll out new restrictions on several products blended with hydrocodone, which has turned out to be a highly prescribed and addictive painkiller in America.
Regulatory Affairs > News
EISAI seeks approval to expand antiepilepsy agent Fycompa as adjunctive cure of primary generalised tonic-clonic seizures
By PBR Staff Writer
Eisai announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
Regulatory Affairs > News
FDA authorizes Kronus ZnT8Ab Elisa Assay for marketing
By PBR Staff Writer
The US Food and Drug Administration (FDA) has authorized the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that helps in determination of Type 1 Diabetes.
Regulatory Affairs > News
US DoJ clears AstraZeneca’s clinical trial
By PBR Staff Writer
The United States Department of Justice (US DoJ) has concluded its probe into PLATO clinical trial for AstraZeneca's Brilinta (ticagrelor), with no further action required.
Regulatory Affairs > News
FDA approves Cerdelga for Type 1 Gaucher disease treatment
By PBR Staff Writer
Genzyme-built drug Cerdelga has been approved by the US Food and Drug Administration (FDA) to treat adult patients with the Type 1 form of Gaucher disease.
Regulatory Affairs > News
Pfizer submits NDA for breast cancer treatment Palbociclib to FDA
By PBR Staff Writer
Pfizer has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for palbociclib to treat postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
Regulatory Affairs > News
FDA grants fast track status for Agios' AG-221 to treat acute myelogenous leukemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted Fast Track designation to Agios Pharmaceuticals' AG-221, a first-in-class, oral, selective, potent IDH2 mutant inhibitor, to treat patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.
Regulatory Affairs > News
Biogen's multiple sclerosis drug Plegridy gets FDA approval
By PBR Staff Writer
US-based biotechnology firm Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its Plegridy (peginterferon beta-1a) for the treatment of people with relapsing forms of multiple sclerosis (RMS).
Regulatory Affairs > News
Supernus receives FDA fast track designation for SPN-810
Supernus Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, has announced that the US Food and Drug Administration (FDA) has granted fast track designation for SPN-810 for the treatment of impulsive aggression in attention deficit hyperactivity disorder (ADHD).
Regulatory Affairs > News
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
OncoSynergy's OS2966 glioblastoma treatment gets FDA orphan drug status
By PBR Staff Writer
The FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for US-based biopharmaceutical firm OncoSynergy's investigational drug candidate OS2966, a neutralizing anti-CD29 monoclonal antibody to treat glioblastoma.
Regulatory Affairs > News

PBR Supplier Recommendations

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
Toxikon Europe - Preclinical Safety Studies and QC Testing for the Life Science Community
For more than 30 years Toxikon has been a leading contract research organisation (CRO) providing high-quality preclinical safety studies to the life science community. Toxikon operates state-of-the-art facilities in the US as well as Europe, both locations being FDA registered and ISO 17025 accredited. As a CRO the company offers services in worldwide GMP-GLP compliance testing for the medical, pharmaceutical and biotech industries.... Regulatory Affairs > Suppliers
NSF Health Sciences Pharma Biotech
Since its foundation in 1986, NSF Health Sciences Pharma Biotech has risen to become Europe's largest provider of pharmaceutical education and training with an outstanding international reputation in the fields of pharmaceutical quality management and regulatory compliance. NSF now brings that reputation to the US, complementing its EU expertise with experts in FDA and other markets to offer education and training programs, consultancy and auditing services.... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

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 Monitoring Systems - Sorting Out Wireless By Vaisala pbr
This white paper describes the most common methods of connecting sensors to a monitoring system focusing on selecting wireless options. ... Regulatory Affairs > White Papers See more
1-15 of 3101 results