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Drug & Biologic Product Submissions

This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices for electronic submission compliance for manufacturers and distributors of drug and biologic products.

National Drug Code (NDC) Assignment Guide

Drug Establishment Registration Reporting Requirements

Reed Tech Structured Product Labeling Solutions

FDA Withdraws 216 ANDAs

FDA Withdraws 216 ANDAs

Overview of Pharma Annual Deadlines and Requirements

Overview of Pharma Annual Deadlines and Requirements

Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations

Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations

Achieving Compliance: Pharma Year-End Requirements

Achieving Compliance: Pharma Year-End Requirements

Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus

<img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" class="" width="1080" height="675" srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" />

Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus

Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus

<img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" class="" width="1080" height="675" srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" />

Over-the-Counter Drug Product Monographs: FDA Requirements for Homeopathic Products

Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus

<img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" class="" width="1080" height="675" srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" />

Over-the-Counter Drug Product Monographs: FDA Requirements for Oral Pharma Products

New Drug Application (NDA): Back to the Basics

New Drug Application (NDA): Back to the Basics

Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus

<img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" width="1080" height="675" data-srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" data-src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" data-sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" class="lazyload" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" /><noscript><img src="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png" alt="Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus" class="" width="1080" height="675" srcset="https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-1080x628.png 1080w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-980x513.png 980w, https://www.reedtech.com/wp-content/uploads/2021/06/Copy-of-Copy-of-SPL-OTC-In-progress-1-480x251.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" />

Over-the-Counter Drug Product Monographs: FDA Requirements for Topical Pharma Products

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