Tag Archives: marketing application

New FDA Guidances from April 2012

Here’s a list of the notable guidances released by FDA in April 2012. Continue reading

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FDA Reorganizes Oncology and Hematology Divisions

When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office … Continue reading

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Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, … Continue reading

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Clinical Trials in South Africa 101

South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment … Continue reading

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2010 New Drug Approvals

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.

While the list isn’t long, a few new products stand out to me. Continue reading

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