# Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/comparative-analyses-and-related-comparative-use-human-factors-studies-for-a-drug-device-combination-product-submitted-in-an-anda-draft-guidance-for-industry/c8e96dc7-4f82-494f-ae7f-c75cb0d5808d > FDA guidance document: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry. Issue date: January 17, 2017. Get complete insights and analysis. --- ## Details - Title: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2017-01-17 - Comment Close Date: 2017-03-13 - Last Changed: 2020-05-06 - Docket Number: FDA-2016-D-4412 ## Related Documents - [Establishing Impurity Specifications for Antibiotics](https://www.globalkeysolutions.net/guidances/guidance-document/establishing-impurity-specifications-for-antibiotics/5bb8badb-7c32-4b76-bfc9-bbb8ab55fb84) - [Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application](https://www.globalkeysolutions.net/guidances/guidance-document/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new-drug-application/1da84f16-4374-4eb9-87cd-f13d1d965346) - [How To Obtain a Covered Product Authorization](https://www.globalkeysolutions.net/guidances/guidance-document/how-to-obtain-a-covered-product-authorization/881f0322-95f9-4bfd-b6c3-35f5df950808)