On September 29, 2021, The Food and Drug Administration (FDA), released a proposed benefit-risk assessment for new drug and biological products. The document, published in draft guidance form, shines a spotlight on the FDA’s decision-making processes.
Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, FDA inspections, supply chain, biopharma, biomedical research, medical research, supply chain management, medical device manufacturer, supply chain shortage, food and drug administration
Imagine being diagnosed with an incurable disease. Now, imagine being diagnosed with an incurable disease that affects less than 2,000 people globally. That’s the reality more than 300 million people are living worldwide. The reality of life with a rare disease.
Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, supply chain, biopharma, biomedical research, medical research, supply chain management, medical device manufacturer, supply chain shortage, rare disease awareness, rare diseases, genetic diseases
For more than a year now, the global supply chain has experienced significant disruptions. At the beginning of the COVID-19 pandemic, factories manufacturing everyday objects like semiconductors, personal protective equipment, and bicycles, shut down resulting in global product shortages and long-lasting headaches for many business owners.
Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, supply chain, biopharma, biomedical research, medical research, supply chain management, medical device manufacturer, supply chain shortage
