A Rundown on NEW Updates of FDA's Clinical Trial Data Submission Guidelines

In October 2017, an updated version of the FDA’s Technical Conformance Guide (TCG) was released.  The TCG has been around for about 4 years and provides recommendations on how ...
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Philadelphia’s Biotech Real Estate Market is About Location, Location and Tax Breaks

The Navy Yard – a Life Science Hub (pictured) As mentioned in our previous post, Philadelphia is positioning itself as a top life science biotech hub.  One of the top reasons ...
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5 Reasons Philadelphia is An Attractive Hub for Biotech

This year, Philadelphia jumped up two spots and ranked #5 for a thriving biotech hub, according to a study by the research firm, JLL.  This came as no surprise to us, since ...
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Is Your Company Ready for the 21st Century Cures Act?

As most biopharmaceutical groups are aware, the 21st Century Cures Act of 2016 mandates a number of powerful core changes to drug and medical device development timelines. ...
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Common Pitfalls When Submitting Clinical Trial Study Data

Good quality clinical trial study data that comes through the FDA could potentially avoid delay in data extraction, review and verification that will help drive your product to ...
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What to Consider Before Conducting a First In Man Trial

Conducting a First In Man (FIM) clinical trial with a novel drug product is a complicated process that requires an abundance of caution. Also known as Phase 0 trials, FIM ...
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Do You Need an IND for Clinical Trials?

Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. ...
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Successful Clinical Trials in Immunooncology Are Just Getting Started

Pictured: The antibody binding domain of nivolumab, bound to PD-1. Image source: Dr. David S. Goodsell of the Scripps Research Institute. Public domain, accessed via Wikimedia ...
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5 Key Trends Shaping the Future of Drug Development

The FDA’s Center for Drug Evaluation and Research (CDER) offers an all-encompassing bundle of information that is of interest to the pharmaceutical industry to help get their ...
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