Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers

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and Packers</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda" title="Reporting Serious Problems to FDA"> Reporting Serious Problems to FDA </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a 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href="mailto:?subject=Drug%2FBiologic%2FHuman%20Cell%2C%20Tissues%20and%20Cellular%20and%20Tissue-Based%20Product%20Manufacturers%2C%20Distributors%2C%20and%20Packers&body=https://www.fda.gov%2Fsafety%2Freporting-serious-problems-fda%2Fdrugbiologichuman-cell-tissues-and-cellular-and-tissue-based-product-manufacturers-distributors-and" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>Information on mandatory reporting:</p> <h3>Applicable Regulations</h3> <p>You can search the FDA's <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm"><strong>CFR Title 21 Database</strong></a> for the latest regulations. The links below will take you directly to the relevant section.<br>  </p> <ul> <li><strong>Drugs</strong> <ul> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.305">21 CFR 310.305</a> -- Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.</li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32">21 CFR 312.32</a> -- IND Safety Reports.</li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80">21 CFR 314.80</a> -- Postmarketing reporting of adverse drug experiences.</li> </ul> </li> </ul> <ul> <li><strong>Biologics</strong> <ul> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32">21 CFR 312.32</a> -- IND Safety Reports.</li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=600.80">21 CFR 600.80</a> -- Postmarketing reporting of adverse experiences.</li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.350">21 CFR 1271.350</a> -- Human Cells, Tissues, and Cellular and Tissue-Based Product Reporting</li> </ul> </li> </ul> <p> </p> <h3>Guidance for Industry</h3> <ul> <li><a href="/drugs/guidances-drugs/electronic-submissions">Guidances on Electronic Submissions</a></li> <li> <p>Postmarketing Reporting of Adverse Experiences</p> <ul> <li><a href="/media/73593/download" target>Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines</a></li> <li><a href="/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/human-cell-tissue-products-hctp-adverse-reaction-reporting" target>Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting</a></li> </ul> </li> </ul> <p> </p> <h3><a href="/safety/reporting-serious-problems-fda/referencing-fdas-medwatch-program">Referencing FDA's MedWatch Program</a></h3> <h3><a href="/safety/reporting-serious-problems-fda/where-send-completed-form-fda-3500a-mandatory-reporting-form" target>Where to send</a> mandatory reporting forms</h3> <h3><a href="/safety/reporting-serious-problems-fda/medwatch-manufacturer-program">MedWatch to Manufacturer Program</a></h3> <h3><a href="/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions">FDA Adverse Events Reporting System (FAERS)</a></h3> <ul> <li>Postmarketing expedited and periodic individual case safety reports with and without attachments acceptable in electronic format without paper records (effective November 29, 2001)</li> </ul> <h3>Federal Register Publications Related to Postmarketing Reporting</h3> <p>[External link to the <a href="http://www.gpoaccess.gov/fr/search.html" target="_blank"><strong>Federal Register Search</strong></a>]<br>  </p> <ul> <li>5/04/2001: <strong>Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports; Availability - NOTICE </strong><br> [Docket No. O1D-0185] Vol. 66, No. 87, pg. 22585 - 22586</li> <li>3/12/2001: <strong>Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Availability - NOTICE </strong><br> [Docket No. O1D-0056] Vol. 66, No. 48, pg. 14391 - 14392</li> <li>11/05/1998: <strong>Electronic Reporting of Postmarketing Adverse Drug Reactions; Request for Comments - Advanced Notice of Proposed Rulemaking (21 CFR Parts 310, 314, and 600)</strong><br> [Docket No. 98N-0750] Vol. 63, No. 214, pg. 59746 - 59750</li> <li>10/07/1997: <strong>Expedited Safety Reporting Requirements for Human Drug and Biological Products - Final Rule (21 CFR Parts 20, 310, 312, 314, and 600)</strong><br> [Docket No. 93N-0181] Vol. 62, No. 194, pg. 52237 - 52253</li> <li>06/25/1997: <strong>Postmarketing Expedited Adverse Experience Reporting for Human Drug and Licensed Biological Products; Increased Frequency Reports - FINAL RULE (21 CFR Parts 310, 314, and 600)</strong><br> [Docket No. 96N-0108] Vol. 62, No. 122, pg. 34166 - 34168</li> <li>05/19/1997: <strong>International Conference on Harmonisation; Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; Availability - NOTICE</strong><br> [Docket No. 96D-0041] Vol. 62, No. 96, pg. 27470 - 27476</li> <li>10/1/1996: <strong>International Conference on Harmonisation; Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports; Availability - NOTICE</strong><br> [Docket No. 96D-0236] Vol. 61, No.191, pg. 51287 - 51294</li> <li>04/03/1995: <strong>Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules - FINAL RULE (21 CFR Part 20)</strong><br> [Docket No. 93N-0334] Vol. 60, No. 63, pg. 16962 - 16968</li> <li>03/01/1995: <strong>International Conference on Harmonisation; Guideline on Clinical Safety Data Management; Definitions and Standards for Expedited Reporting; Availability - NOTICE</strong><br> [Docket No. 93D-0203] Vol. 60, No. 40, pg. 11284 - 11287</li> <li>10/27/1994: <strong>Adverse Experience Reporting Requirements for Licensed Biological Products - FINAL RULE (21 CFR Part 600)</strong><br> [Docket No. 93N-0072] Vol. 59, No. 207, pg. 54034 - 54044</li> <li>10/27/1994: <strong>Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products - PROPOSED RULE (21 CFR Parts 20, 310, 312, 314, and 600)</strong><br> [Docket No. 93N-0181] Vol. 59, No. 207, pg. 54046 - 54064</li> <li>06/03/1993: <strong>Form for Reporting Serious Adverse Events and Product Problems with Human Drug and Biological Products and Devices; Availability - NOTICE</strong><br> [Docket No. 93N-0072] Vol. 58, No. 105, pg. 31596 - 31614</li> </ul> <p> </p> <h2>Resources For You</h2> <ul> <li><a href="/media/69876/download">Form FDA 3500A - Mandatory Reporting</a></li> <li><a href="UCM387002">Instructions for Completing Form FDA3500A</a></li> </ul>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2019-11-05T04:32:00Z">11/05/2019</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Drugs</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section 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