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Tag Archives: pre-IND
Pre-IND Submissions in eCTD Format
Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND … Continue reading
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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Vendor Selection – All that Glitters is Not Gold
One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities. Several variables determine what makes a good outsourcing partner – … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged biotech, clinical trials, CMC, CROs, drug development, funding, IND, manufacturing, nonclinical research, outsourcing, pre-IND, regulatory affairs
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Guidance for the Therapeutic Discovery Tax Credit
Credit you give yourself is not worth having. – Irving Thalberg For all you virtual biotechs and small start-up biotechs that survived the “Great Recession,” here is something to look forward to. I’ve mentioned the Therapeutic Discovery Tax Credit before, … Continue reading
Posted in Industry News
Tagged biomedical, biotech, CMC, FDA, GLP, IRS, Phase 1, Phase 2, pre-IND, tax credit
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Nonclinical Program Considerations for a Pre-IND Meeting
Developing a well–thought-out nonclinical program is an evolving process. The number and types of animal studies impact not only funding requirements, when an IND will be filed, and whether the IND will be cleared, but also what the starting dose … Continue reading
Posted in Clinical Trials, FDA, Regulatory Strategy
Tagged FDA, IND, nonclinical research, pre-IND
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