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  • I don't understand why the RAPS tries to limit who can take the exam. I am finally going to be coming up on three years in regulatory editing (1 year at Genentech as a CMC editor and almost 2 years in pharma/biotech advertising), but it would have made more sense for me to study for and take the exam while I was at Genentech in CMC editing. ------------------------------ ...

  • FDA would ask you to submit two separate NDAs because they are two different dosage forms (immediate release-IR and Delayed release) so you will need two different labels for submission. Hope this helps! ------------------------------ GRSAOnline ------------------------------

  • Huge growth room for combination device in China as the first batch of approved products was just released a year ago. In 2017, CFDA announced the first batch of approved combination products since the release of the combination product registration guideline in 2009. There are currently four combination products approved by CFDA . If a manufacturer ...

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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