What You Need to Know About the FDA’s MedWatch Adverse Event Reporting Program

If you are a small business working with the FDA to get a drug or medical device on the market, you are aware of the scrutiny of clinical trial design and data to ensure the ...
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Tips for Preventing Medication Errors in Clinical Trials

The integrity and safety of a clinical trial greatly depends on adherence to the carefully considered and approved administration protocol for a new investigational drug.  ...
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Need-to-Know FDA Resources for Small and Mid-Size Biotechs

The immense amount of information on the FDA website is overwhelming even to the most seasoned regulatory professional.  Yet, start-up and small biotech companies need to have ...
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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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