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Tag Archives: oncology
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
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged CDER, FDA, hematology, marketing application, oncology, toxicology, tumors
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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
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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Conference Recap – Biomarker World Congress 2011
Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients. Specifically, personalized medicine is dedicated to the concept hat the right drug is … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biomarkers, breast cancer, cancer, Chemotherapy, clinical trials, efficacy, oncology, personalized medicine, Phase 1, Phase 2, validation
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Recap of the NCCN 16th Annual Conference
The 16th Annual National Comprehensive Cancer Network Conference (NCCN): Clinical Practice Guidelines and Quality Cancer Care, was held on 09-13 March 2011 in Hollywood, FL. The conference hosted almost 2,000 registrants including oncologists, nurses, pharmacist, and other health care professionals. … Continue reading
Posted in Conferences and Meetings
Tagged cancer, clinical trials, conference, FDA, oncology
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35th European Society for Medical Oncology Congress
Image via Wikipedia The annual European Society for Medical Oncology (ESMO) meeting brings together medical oncologists from both Europe and all parts of the world. As per ESMO’s 2010 meeting President, Dr. David Kerr, announcement: The ESMO Congress is a … Continue reading
