What's New in the Updated FDA Guidance on Electronic Records and Signatures

In June of 2017, the FDA released an updated guidance for clinical investigators, and any other associated parties, that use electronic records and signatures in their drug ...
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What's the Difference Between an Umbrella Study and a Basket Study?

New methods of clinical trial design are thought to allow more patients to participate and test new treatments at a faster rate.  Two relatively new types of studies for cancer ...
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How the Industry Can Help With New FDA Guidance on Generic Drug Development

In order to facilitate timely access to high quality, affordable generic medicines, the FDA has implemented two drug program enhancements with the goal of improving ...
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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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