Why 2017 Was Such a Big Year for Drug Approvals

Even though 2016 was an unusually slow year for FDA drug approvals, in 2017 the number of new drugs sent to market more than doubled.  Forty-six drugs, to be precise, passed ...
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3 Key Concepts In the Development and Approval of Biosimilars

Pictured: A 3D rendering of Factor VII, one of the proteins that causes blood to clot in the coagulation cascade.
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Beyond Labeling: How the FDA Ensures Drug Safety

In 2007, a new law was passed that gave the FDA new authorities and responsibilities to enhance drug safety. It's called the Food and Drug Administration Amendments Act and one ...
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The Who, What, Why, When and How for Registering New Drugs

In the US, there are registration and listing requirements for new drugs going into clinical trials and the companies that manufacture these drugs.  Do you know if these ...
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Three Cheers to the Local Community: A Recap of our December Biotech Fundraiser

On December 7th ClinSmart hosted a Biotech/ Life Science Community Fundraiser at our HQ in Newtown, Pennsylvania (USA). This was a follow-up to a similar event hosted in August ...
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Best Practices for Communication Between the FDA and Your IND sponsor

Each biotech company has a different culture, communication style, set of preferences, and documentation needs, so there is essentially no single best communication method ...
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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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