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 some degree of familiarity with the organization’s processes and databases as they move their product forward onto the market.  To aid in this endeavor, we have carefully chosen and briefly described some useful websites, search engines and tools that you may utilize to help you navigate the complex system of the FDA.

 

FDA’s Drug Development Flow Chart

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What is it:  A simple decision tree designed to guide an industry professional through a series of questions and answers related to the FDAs drug regulation processes.

Main uses:  To navigate and understand if your planned activities would be subject to FDA regulation. 

Fast fact:  A general overview of products that the FDA regulates can be found here.

Free ebook download: Learn the 4-step process that simplifies the site  budgeting process.

Industry Frequently Asked Questions and Answers

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What is it:  A comprehensive list of common Q&A on subjects ranging from drug reviews, approvals, and listings.

Main uses:  To take a deeper dive into the FDA drug regulation process and approval proceedings.

Fast fact:  You can rate the answers to the questions.  This allows them to better meet the needs of the consumer.

 

Small Business Assistance Workshops and Webinars

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What is it: Content-rich series of webinars and workshops with up-to-date information on FDA human drug development and regulation processes.

Main uses:  Educational assistance to help deliver an efficient approval process and provide safe and effective human drugs on the market.

Fast fact:  This program also publishes a newsletter every other month, highlighting various regulatory issues most relevant to small/mid-size biotech companies.

 

Drugs@FDA 

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What is it:  Search engine that allows to find official information on FDA approved innovator or genetic drug products including therapeutics, such as monoclonal antibodies.

Main uses:  To understand the market landscape and find generic drug products for an innovator drug product, finding therapeutic equivalent of an innovator or generic drug product, and review the approval history.

Fast Fact:  Includes drugs that were FDA approved since 1939. 

 

Finally, click here to sign up for tools based on your interests to keep you informed including e-mail alerts, news feeds and podcasts on all things FDA related.  Did we miss an important FDA resource?  Please let us know by commenting below.

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