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# FDA to Roll Out ‘Program Alignment’ in May
- URL: https://www.fdaweb.com/fda-to-roll-out-program-alignment-in-may/
- Published: 2017-01-30T12:00:00.000Z
- Updated: 2026-09-14T22:03:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137856

FDA’s Office of Regulatory Affairs (ORA) plans to implement its long-awaited Program Alignment Group [initiative](http://fdaweb.com/login.php?sa=v&aid=D5126282&searchWords=Program%20Alignment%20Group&cate=S&stid=%241%24a1..bM0.%24Ldew.kgr.r0hp69Zd9qOh0&ref=fdaweb.com) by 5/15\. Under the plan, the field force will shift to a commodity-based, vertically integrated inspection program, with specialized inspection cadres for FDA-regulated products and inspection operations. “ORA will maintain 20 district offices across the U.S.; some will concentrate on certain product areas, such as food or drugs, with additional specialists covering other areas,” according to a [report](http://www.appliedclinicaltrialsonline.com/fda-moves-implement-new-site-inspection-program?ref=fdaweb.com) published in *Applied Clinical Trials*.

  
To roll out the program, ORA now has senior-level program directors at FDA headquarters in Maryland who oversee operations for six main product areas — food, biologics, drugs, medical devices, bioresearch monitoring (BIMO), and tobacco, plus operations involving imports and ORA laboratories. Each district office will have a director and program managers to head inspection cadres at each location, according to a [related report](http://www.pharmtech.com/fda-moves-forward-inspection-overhaul?ref=fdaweb.com). ORA plans to roll out more details and organizational information over the coming weeks.