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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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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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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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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