RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Regulatory Update

Regulatory Update

Posted 01 March 2010 | By

The US Food and Drug Administration (FDA) announced the availability of Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names. This document will assist manufacturers in completing the submission, which is required for the review clock to begin. It will also help the agency evaluate the safety of proposed proprietary drug and biological product names by taking into account factors that can contribute to medication errors. In this guidance FDA discusses the information it requires from the manufacturers for the assessment of:

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.