FDA's Rulemaking process

The food and drug agency (FDA) issues regulations to the public notifying them of the various actions taken by the agency. Such regulations are either required or authorized by statute. As Ruder & Woods (2020) highlighted, the FDA’s egg safety regulations for example, are aimed at addressing identified problems or hazards while on the other hand, citizen petition regulations are either procedural or administrative. The current rule making procedure come from a memoranda issued by the president, US law and the FDA’s own regulation.

The process that is often used to issue the rules in normally called “notice and comment rule making”. Issuance of the proposed rule is the first step in the notice and comment rule making process. The proposed rule issued by the agency gives a detailed information of the agency’s intentions and basis, they then ask for public comments (Davis & Miller, 2017). After the agency receive and review the public comments they decide on whether there is need f...