Drugs

CDER Equal Voice MAPP

FDA has published a CDER Manual of Policies and Procedures, Equal Voice Collaboration and Regulatory and Policy Decision-Making in CDER, describing the principles behind the Center’s Equal Voice and how the process is used for collaborative review and regulatory and policy decision-making. The MAPP says CDER uses Equal Voice to:

seek and engage all relevant expertise into the regulatory and policy decision-making process;
enable professional opinions to be fully expressed, understood, considered, and documented;
strive to achieve alignment (support for a decision, not necessarily the same as agreement);
provide informal and formal means to resolve differences of professional opinion; and
ensure decisions are shared with relevant staff and documented.

The Equal Voice principles and process outlined in the MAPP apply to all CDER staff when making pending regulatory or policy decisions and resolving differences of opinion, it says. The MAPP does not apply to matters pertaining to human resources or labor and employee relations.

The document says that all staff, including CDER supervisors, managers, and senior managers, are expected to adhere to and support the Equal Voice principles and process. “Staff support Equal Voice by creating an inclusive and safe environment that encourages participants to voice their professional opinions,” it says, “even when they differ from prevailing views, pending decisions, or proposed or established practices.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome