21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]

200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

What are the potential areas of risk management?

  The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark. In a very broad sense, the potential areas of […]

Statins ‘should be given to children with heart risks before the age of 10’

Statins should be given to thousands of children by the age of 10 under radical new NHS guidance. GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected. Estimates suggest up to 260,000 people – including 50,000 children – are […]

Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial. The results were part of a recent update that Vertex Pharmaceuticals provided on Orkambi and three of its other CF therapies, Kalydeco (ivacaftor), tezacaftor (VX-661) and VX-371. Vertex […]

8 Tough Questions Every CISO Should Be Ready to Answer

When a major security incident, such as the recent massive Equifax data breach, grabs headlines, CEOs start asking more questions about data security. See Also: Addressing the Identity Risk Factor in the Age of ‘Need It Now’ CISOs need to be thinking about their answers to critical questions the CEO is likely to pose. Information […]

Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

Posted 11 September 2017 By Zachary Brennan FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective. Opening with a discussion of the ways in which the gap of time between the discovery of […]