FDA Restricts Use of Codeine and Tramadol in Children

On April 20, 2017, the Food and Drug Administration (FDA) issued a safety announcement restricting the use of codeine and tramadol medicines in children. Codeine and tramadol are a type of narcotic medicine called an opioid. Codeine is indicated to treat mild to...

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Rx Research Solutions Sponsors 6th Annual CROWN Congress

Rx Research Solutions is proud to sponsor this year's Clinical Research & Operations Worldwide Networking (CROWN) Congress, which will be in  Philadelphia, PA from March 7- 9. We hope you will join us for this three day, three track, four workshops, 30+ Sessions...

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Notes 2 Fix your Notes 2 File

by Laurie Meehan & Lauren Kelley Q: If Notes to File can be regulatory red flags, should you quit using them? A: No, and here’s why… Regulatory inspections are often conducted long after the conclusion of the study. When an FDA investigator asks you a question...

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When GCP & GMP Meet

by Laurie Meehan & Rosanne Sylvia-Heeter Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can...

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Site Selection: Don’t Forget About the Study Drug

by Laurie Meehan & Lauren Kelley As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol,...

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