FDA’s latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC

• Post approval changes to approved applications. The proposed rule would update the existing regulations on supplements to approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) and regulations on certain post-approval reports.
• Current good manufacturing practices (GMPs) for positron emission tomography (PET) drugs. The proposed rule would delete a reference to an outdated United States Pharmacopeia (USP) chapter and streamline requirements to make them applicable to the production, quality assurance, holding, and distribution of all PET drugs, including investigational and research PET drugs. It would replace regulations published in December 2011.
• Current GMPs for outsourcing facilities. The proposed rule would set minimum GMPs for drug products compounded by an outsourcing facility. This has been listed in past regulatory agendas.
• Postmarketing safety reporting requirements for drug and biological products, the proposed rule would modernize FDA’s regulations on postmarketing safety reporting and pharmacovigilance by capturing new safety information, improving the quality of submitted reports, and supporting enhanced efficiency and alignment with internationally harmonized reporting guidelines. This has also been listed in past agendas.
• Pediatric study plan requirements for new drugs and biologics. The proposed rule would amend its existing regulations and add new regulations covering initial pediatric study plans (iPSPs) as laid out under the Food and Drug Administration Safety and Innovation Act of 2012. This rulemaking is long overdue and was supposed to be in place in 2013.
• Drug establishment registration and drug listing requirements. The proposed rule would revise the regulations under 21 CFR 207 to clarify that drug establishment registration and drug listing requirements are applicable to foreign drug manufacturing establishments that do not import to the US but are still involved in the drug manufacturing of products that are imported in the US. This proposed rule has been included in previous agendas.

• Protection of human subjects. The final rule would harmonize certain provisions of FDA’s regulations covering human subject protections and IRBs with the revised policy of Common Rule on the Federal Policy for the Protection of Human Subjects. A proposed rule was published in September 2022.
• Reclassification of immunology and microbiology devices, human leukocyte antigen (HNA), neutrophil and platelets and antibody tests: FDA plans to issue a final rule to place these devices into Class II and is identifying special controls for these devices to provide a “reasonable” assurance of safety and effectiveness. A proposed rule was issued in January 2022.
• Investigational new drug applications and annual reporting: FDA plans to issue a final rule to amend its requirements on annual reports submitted by sponsors by replacing annual reporting with a new requirement for an FDA development safety update report (FDA DSUR). A proposed rule was published in December 2022.
• Revising the National Drug Code (NDC) format. FDA plans to issue a final rule to revise the format of the NDC to standardize the format of all NDCs, requiring them to consist of 12 digits instead of the current 10-digit format. FDA is overdue in issuing this rule. A proposed rule was issued in July 2022.
• Electrical stimulation devices intended for self-injurious behavior or aggressive behavior: FDA is planning to issue a final rule that would ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). A proposed rule was issued in March 2024.
• Revocation of mutual recognition agreement of pharmaceutical GMPs and medical device quality systems audits and medical device product evaluation reports between the US and the EU: The final rule will revoke the regulations related to pharmaceutical GMPs while retaining medical device product evaluation reports. This action is being taken because the existing regulation on pharmaceutical GMPs have been superseded by the 2017 MRA pharmaceutical annex. A proposed rule was issued in September 2024.
• Recission of laboratory development tests (LDTs). FDA plans to rescind the final rule concerning LDTs that was issued under 21 CFR 809.3(a). This rule had added the phrase “including when the manufacturer of these products is a laboratory.” FDA plans to revert to the previous wording of the regulations. The final rule was issued in May 2024.