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Regulatory Affairs

Genentech's Rituxan gets FDA breakthrough therapy status to treat pemphigus vulgaris By PBR Staff Writer
Roche’s subsidiary Genentech has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Rituxan (rituximab) to treat pemphigus vulgaris.
Regulatory Affairs > News
Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.
Regulatory Affairs > News Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma By PBR Staff Writer
Merck’s EMD Serono and Pfizer have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).
Regulatory Affairs > News
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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
Genentech's Rituxan gets FDA breakthrough therapy status to treat pemphigus vulgaris
By PBR Staff Writer
Roche’s subsidiary Genentech has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Rituxan (rituximab) to treat pemphigus vulgaris.
Regulatory Affairs > News
Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases
Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.
Regulatory Affairs > News
Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma
By PBR Staff Writer
Merck’s EMD Serono and Pfizer have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).
Regulatory Affairs > News
NSF: What Does Your Company QMS Look Like? Where Does Senior Management Fit In?
NSF was asked by top management to review the range and extent of GxP quality systems in place and make recommendations for a single company-wide QMS suitable for its modern business model and meeting all anticipated regulatory requirements.
Regulatory Affairs > Case Studies
NSF: Does Your Pharmaceutical Quality System Improve Your Competitive Edge?
There are some companies who believe that their Pharmaceutical Quality System (PQS) exists purely for regulatory compliance. We think this attitude is outdated and plainly wrong. At NSF, we believe that your PQS has only one purpose: to improve your competitive edge by guaranteeing the manufacture of high quality medicines at the lowest possible cost. We have worked in partnership with many of our clients to help them improve their PQS and their competitive edge. The following results give you a flavor of what can be achieved and how.
Regulatory Affairs > Case Studies
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