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Top 10 Myths About Working with the FDA for an Oncology Drug Approval
Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.
Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19
The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...
How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance
The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...
Commercial and regulatory strategy considerations for biotech
In this blog, Parexel regulatory and strategy experts tackle the question of how we can ensure that worthy innovations in the biotech pipeline make it to patients sooner.
Improving Drug Development & Patient Access With the Right People, Processes, and Culture
What To Consider When Mapping Your Strategy For Submitting An Application To The National Drug Administration of China
Brochure: Regulatory, Development and Commercial Expertise. Operational Excellence. One Source.
Patient Recruitment in Asia
Learn about patient recruitment strategies in Asia that will reduce the clinical trial burden, as published in Pharma Focus Asia in January 2018.