Independent evaluations of activities, processes and products are essential to any organization concerned with quality management, especially those involved with pharmaceuticals and drug development.
When it comes to clinical research, independent GCP audits provide an important glimpse into the quality of the research being conducted while assessing the effectiveness of the standard operating procedures guiding your work.Continue Reading
When a serious medical condition goes without suitable treatment, the FDA offers four programs to fast-track potential drugs through the development and review stages:
• Breakthrough therapy
• Accelerated approval, and
• Priority review
As we’ve learned from working with clients over the years, deciding which program is best suited for a potential product isn’t always easy. That’s why we work closely with you and your product to determine which program offers the best path forward depending on how your data satisfies the requirements of each.Continue Reading
Last July, the FDA released a draft guidance on the oversight of lab-developed tests. Since then, the American Clinical Laboratory Association (ACLA) and other medical associations have spent the past year battling the proposed regulations both though tough words and the threat of legal action.
The new regulations, which would subject large centralized laboratories to the FDA’s stringent oversight, are an attempt by the FDA to more closely oversee tests they say “may have caused or have caused” harm to patients by misdiagnosing potentially serious conditions.
After months of revisions following the initial draft guidance, the new rules would regulate LDTs under existing medical device laws, forcing companies to submit more evidence regarding products’ safety and accuracy.Continue Reading
“Leading with 2020 vision” was the theme of this year’s Vistage Executive Summit––an event aimed at helping business leaders stay relevant today’s fast-paced, technology-driven culture by giving executives a platform to share insights and firsthand experience.
Among the speakers and breakout sessions at this year's event in Boston, The FDA Group’s CEO and President Nick Capman sat down with Soyini Coke to discuss the state of the pharmaceutical industry, FDA compliance, and more on the CEO Exclusive Broadcast.Continue Reading