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Regulatory Affairs
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NSF’S New Highly Interactive Pharmaceutical Training Workshops for 2017/2018
We have listened to you and taken your feedback on board to create our new pharmaceutical training workshops for 2017/2018.
Regulatory Affairs > Press Releases
Merck, Pfizer get EC approval for skin cancer drug Bavencio
By PBR Staff Writer
Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.
Regulatory Affairs > News
Roche gets EC nod for Gazyvaro to treat advanced follicular lymphoma
By PBR Staff Writer
Roche has secured approval from the European Commission (EC) for its Gazyvaro (obinutuzumab) in combination with chemotherapy for the treatment for previously untreated advanced follicular lymphoma.
Regulatory Affairs > News
Novartis’ Rydapt approved in Europe for AML and rare blood disorders
By PBR Staff Writer
Novartis’ cancer drug Rydapt (midostaurin) has been approved by the European Commission (EC) for a mutated form of acute myeloid leukemia (AML) and certain rare blood disorders.
Regulatory Affairs > News
Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery
Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
Regulatory Affairs > News
Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea
Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Regulatory Affairs > News
GSK, Innoviva get FDA nod for COPD treatment Trelegy Ellipta
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva have secured approval from the US Food and Drug Administration (FDA) for once-daily and single inhaler triple therapy, Trelegy Ellipta, to treat patients with chronic obstructive pulmonary disease (COPD).
Regulatory Affairs > News
FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment
The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.
Regulatory Affairs > News
PQG 40th Anniversary – Meet NSF, 9-11 October, Milton Keynes, UK
To celebrate their 40th anniversary, the Pharmaceutical Quality Group (PQG) are holding an anniversary dinner on the evening of Monday, 9 October and a three-day meeting from 9 to 11 October at the Hilton Hotel in Milton Keynes, UK.
Regulatory Affairs > Press Releases
NSF: The Journal Issue 39 - Simplicity - Critical For Success In Your Quality System
This edition focuses on simplicity in relation to your pharmaceutical quality system.
Regulatory Affairs > Press Releases
SHL to Showcase Latest Innovations at PDA Universe of Pre-filled Syringes & Injection Devices
SHL Group is to present its range of new devices and innovative technologies at the 2017 Parenteral Drug Association Universe of Pre-filled Syringes and Injection Devices.
Regulatory Affairs > Press Releases
Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
Regulatory Affairs > News
FDA approves biosimilar of Avastin to treat five types of cancer
By PBR Staff Writer
Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Mvasi (bevacizumab-awwb), a biosimilar to Roche's Avastin, to treat five types of cancer.
Regulatory Affairs > News
Regeneron, Sanofi get FDA breakthrough therapy status for skin cancer drug cemiplimab
By PBR Staff Writer
Regeneron Pharmaceuticals and Sanofi have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for cemiplimab (REGN2810) to treat advanced cutaneous squamous cell carcinoma (CSCC).
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
See more

PBR White Paper Recommendations

SHL Group: Auto Injectors - From Planning to Launch By SHL Group
Preparing for the overall development process.... Regulatory Affairs > White Papers 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 See more
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