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Regulatory Affairs
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Eagle gets complete response letter from FDA on stroke drug RYANODEX
Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
Regulatory Affairs > News
GSK receives FDA approval for self-injectable Benlysta formulation
GSK has secured approval from the US Food and Drug Administration (FDA) for a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE), who are receiving standard therapy.
Regulatory Affairs > News
Merck secures tentative FDA approval for Lusduna
The US Food and Drug Administration (FDA) has given a tentative approval for LUSDUNA Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device.
Regulatory Affairs > News
Leo Pharma gets EC nod for psoriasis treatment Kyntheum
By PBR Staff Writer
AstraZeneca’s subsidiary MedImmune announced that its partner Leo Pharma has secured approval from the European Commission (EC) for its Kyntheum (brodalumab) to treat moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
FDA approves Gilead’s Vosevi to re-treat HCV infection in adults
By PBR Staff Writer
Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for its Vosevi to re-treat adults with chronic hepatitis C virus (HCV) infection.
Regulatory Affairs > News
FDA rejects Amgen’s BLA for osteoporosis treatment Evenity
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Amgen and UCB’s biologics license application (BLA) for Evenity (romosozumab) to treat postmenopausal women with osteoporosis
Regulatory Affairs > News
J&J’s Janssen Biotech gets FDA nod for Tremfya to treat plaque psoriasis
By PBR Staff Writer
Johnson & Johnson (J&J) subsidiary Janssen Biotech has secured approval from the US Food and Drug Administration (FDA) for its Tremfya (guselkumab) to treat adults with moderate to severe plaque psoriasis.
Regulatory Affairs > News
FDA advisory committee recommends Novartis’ CTL019 for r/r B-cell ALL
By PBR Staff Writer
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended Novartis’ CTL019 (tisagenlecleucel) to treat relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
FDA accepts BMS’ sNDA to review Sprycel in Philadelphia CP CML
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) submitted by Bristol-Myers Squibb (BMS) for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML).
Regulatory Affairs > News
Vaisala: McKesson Specialty Health Achieves over 100 Audits without a Single Observation
Bullet-proof environmental monitoring technology that answers auditors’ questions.
Regulatory Affairs > Case Studies
Shire submits IND for hemophilia A treatment in US
By PBR Staff Writer
Shire has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its gene therapy drug, SHP654, to treat hemophilia A.
Regulatory Affairs > News
Japan's MHLW approves Olumiant to treat rheumatoid arthritis
Eli Lilly and Company and Incyte announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
Regulatory Affairs > News
FDA approves Triptodur to treat central precocious puberty
Arbor Pharmaceuticals and Debiopharm International announced that the US Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal - before age 8 in girls and 9 nine in boys.
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 asks why Annex 1 is Important to you By NSF Health Sciences Pharma Biotech PBR
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.... Regulatory Affairs > White Papers Heightened FDA Enforcement for Sterility Issuesin Pharma Biotech with NSF By NSF Health Sciences Pharma Biotech PBR
NSF analysed all of the warning letters issued to pharma and biologic manufacturers for sterility issues since 2015. This white paper provides detailed insight into our analysis. It includes relative charts and a table with a summary of the regulations cited by the FDA as well as recommendations for closing your compliance gaps. ... Regulatory Affairs > White Papers NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing By NSF Health Sciences Pharma Biotech PBR
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.... Regulatory Affairs > White Papers NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product By NSF Health Sciences Pharma Biotech PBR
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help. ... Regulatory Affairs > White Papers 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 See more
1-15 of 3805 results