News You Can Use

According to Dictionary.com, the verb “curate” means “to pull together, sift through, and select for presentation, as music or website content.” (The British also use “curate” as a noun to refer to “a member of the clergy employed to assist a rector or vicar”, but we digress.) News You Can Use is our attempt to curate information that would be helpful for our readers. The items range from useful information found on the FDA website and other sources to tips from our employees for R&D companies.

Staying Knowledgeable About FDA Changes

February 20th, 2018
Are you developing a new parenteral formulation?  An orphan drug or a drug delivery system? Are you working on a clinical trial design? If you’re involved with the development of new drugs, you’re probably keenly aware that the U.S. Food and Drug Administration (FDA) review process is vital for you, but you may not have …

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Are you new to the concept of Current Good Manufacturing Practices (cGMPs)?

November 9th, 2017
IRISYS’ experienced formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials and commercial pharmaceutical products. The cGMP manufacturing team complies with IRISYS’ rigorous Standard Operating Procedures and FDA Guidelines. The Facts About the Current Good Manufacturing Practices section of the FDA website …

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