BIO Submits Comments on CDC Clinical Practice Guideline for Prescribing Opioids
April 11, 2022
On Monday, April 11th, BIO also submitted comments in response to the CDC’s recently published Clinical Practice Guideline for Prescribing Opioids. In the comments submitted, BIO primarily requested that the CDC revise its language referencing naloxone to be consistent with more general and product agnostic references, e.g., FDA-approved opioid overdose reversal medication.
Download Full Comments Below
BIO COMMENT LETTER CDC Guideline for Prescribing Opioids
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
.png){kind=logo}
On Monday, April 11th, BIO also submitted comments in response to the CDC’s recently published Clinical Practice Guideline for Prescribing Opioids. In the comments submitted, BIO primarily requested that the CDC revise its language referencing naloxone to be consistent with more general and product agnostic references, e.g., FDA-approved opioid overdose reversal medication.