http://www.fda.gov/ en http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. Tue, 01 Nov 2022 16:01:50 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) Tue, 01 Nov 2022 14:43:32 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. Tue, 01 Nov 2022 14:41:19 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act. Tue, 01 Nov 2022 14:18:55 EDT FDA http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022 FDA will hold a virtual public meeting on Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation. Tue, 01 Nov 2022 14:11:12 EDT FDA http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022 http://www.fda.gov/news-events/expanded-access/expanded-access-information-industry Expanded Access information for medical product companies and other industry stakeholders Tue, 01 Nov 2022 14:07:22 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-information-industry http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA urges consumers taking these products to immediately talk to their health care professio Tue, 01 Nov 2022 13:58:07 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug http://www.fda.gov/drugs/drug-safety-and-availability/la-fda-advierte-los-consumidores-que-no-compren-ni-usen-los-productos-de-artri-y-ortiga-pues-pueden La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) advierte a los consumidores que no compren ni usen productos comercializados con variaciones de los nombres “Artri” u “Ortiga” debido a ingredientes farmacológicos activos ocultos que son potencialmente peligrosos Tue, 01 Nov 2022 13:57:54 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/la-fda-advierte-los-consumidores-que-no-compren-ni-usen-los-productos-de-artri-y-ortiga-pues-pueden http://www.fda.gov/drugs/news-events-human-drugs/more-cder-conversations Conversation with FDA scientists regarding current events. Tue, 01 Nov 2022 13:18:10 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/more-cder-conversations http://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-fdas-final-guidance-carcinogenicity-testing-pharmaceuticals FDA has issued a final guidance, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonisation; Guidance for Industry,” which introduces a comprehensive and integrative weight of evidence approach to assessing human carcinogenic. Tue, 01 Nov 2022 13:17:16 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-fdas-final-guidance-carcinogenicity-testing-pharmaceuticals http://www.fda.gov/drugs/news-events-human-drugs/cder-conversations Interviews with FDA scientists regarding current events relating to the FDA. Tue, 01 Nov 2022 13:14:15 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/cder-conversations http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-paid-facilities-list This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list: Tue, 01 Nov 2022 12:25:47 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-paid-facilities-list http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Tue, 01 Nov 2022 11:09:16 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers-0 Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers Tue, 01 Nov 2022 09:59:53 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers-0 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022 CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Tue, 01 Nov 2022 09:20:07 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-631755-10282022 Finished Pharmaceuticals/Unapproved New Drug/Misbranded Tue, 01 Nov 2022 09:20:07 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-631755-10282022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/latin-foods-market-631753-10282022 Finished Pharmaceuticals/Unapproved New Drug/Misbranded Tue, 01 Nov 2022 09:20:06 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/latin-foods-market-631753-10282022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-631751-10282022 Finished Pharmaceuticals/Unapproved New Drug/Misbranded Tue, 01 Nov 2022 09:20:06 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-631751-10282022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nephron-pharmaceuticals-corporation-dba-nephron-sterile-compounding-center-llc-644180-10212022 Compounding Pharmacy/Adulterated Drug Products Tue, 01 Nov 2022 09:20:05 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nephron-pharmaceuticals-corporation-dba-nephron-sterile-compounding-center-llc-644180-10212022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcconnell-labs-inc-638958-10182022 CGMP/Finished Pharmaceuticals/Adulterated Tue, 01 Nov 2022 09:20:04 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcconnell-labs-inc-638958-10182022