{"id":21487,"date":"2022-08-19T05:26:22","date_gmt":"2022-08-19T10:26:22","guid":{"rendered":"https:\/\/en.ennov.com\/?p=21487"},"modified":"2022-08-19T05:39:12","modified_gmt":"2022-08-19T10:39:12","slug":"fda-roundup-reg-affairs-reg-ops","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/blog\/regulatory-blog\/fda-roundup-reg-affairs-reg-ops\/","title":{"rendered":"FDA News Roundup for Reg Affairs-Reg Ops"},"content":{"rendered":"\n

In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this blog post, we\u2019ll help you catch up on anything you may have missed.<\/p>\n\n\n\n

Update – eCTD Validation Criteria<\/h2>\n\n\n\n

On May 11, FDA<\/strong> updated their eCTD validation criteria<\/a>. In addition to providing some clarifications, they introduced a new error.<\/p>\n\n\n\n

1738, STF Study ID should match STUDYID or SPREFID listed in the referenced Trial Summary (ts.xpt) file<\/p>\n\n\n\n

Ensure ts.xpt is referenced under the correct STF. If ts.xpt is under the correct STF, update the STUDYID or SPREFID in the ts.xpt and other referenced study data files. Modify your SOPs to ensure that a consistent Study ID (exact match) is used.<\/p>\n\n\n\n

Final – Promotional Labeling and Advertising Materials Submission<\/h2>\n\n\n\n

Providing Regulatory Submissions in Electronic and Non-Electronic Format\u2014Promotional Labeling and Advertising Materials for Human Prescription Drugs; Guidance for Industry<\/a> became effective in April 2022. It pertains to submissions of promotional materials for human prescription drugs (drugs) to the Food and Drug Administration (FDA or the Agency) made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant.<\/p>\n\n\n\n

Specifically, this draft guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER), and explains certain aspects of electronic submission of promotional materials in module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file.<\/p>\n\n\n\n

Update – Providing Regulatory Submissions in Alternate Electronic Format<\/h2>\n\n\n\n

In June, FDA re-issued “Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry<\/a>” (relates to any submission with an exemption or a waiver from filing in eCTD format).<\/p>\n\n\n\n

Final – Providing Submissions in Electronic Format\u2014 Postmarketing Safety Reports<\/h2>\n\n\n\n

In April, FDA published Providing Submissions in Electronic Format\u2014Postmarketing Safety Reports; Guidance for Industry<\/a>.<\/p>\n\n\n\n

This guidance assists industry when making certain regulatory submissions in electronic format to FDA\u2019s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance provides general information on the electronic submission of postmarketing safety reports under the following provisions:<\/p>\n\n\n\n