What's New: Drugs RSS Feed http://www.fda.gov/ en Data Standards Program Strategic Plan and Board http://www.fda.gov/drugs/electronic-regulatory-submission-and-review/data-standards-program-strategic-plan-and-board The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market. Fri, 12 Aug 2022 16:05:16 EDT FDA http://www.fda.gov/drugs/electronic-regulatory-submission-and-review/data-standards-program-strategic-plan-and-board CDER Data Standards Program http://www.fda.gov/drugs/electronic-regulatory-submission-and-review/cder-data-standards-program CDER Data Standards Program Fri, 12 Aug 2022 16:03:12 EDT FDA http://www.fda.gov/drugs/electronic-regulatory-submission-and-review/cder-data-standards-program User Fee Lists http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016. Fri, 12 Aug 2022 15:57:12 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Over-The-Counter Monograph Drug User Fee Program (OMUFA) http://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations. Fri, 12 Aug 2022 15:51:22 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use - 08/10/2022 http://www.fda.gov/drugs/news-events-human-drugs/decoding-guidance-considerations-waiver-requests-ph-adjusters-generic-drug-products-intended Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use Fri, 12 Aug 2022 15:22:45 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/decoding-guidance-considerations-waiver-requests-ph-adjusters-generic-drug-products-intended CDER Small Business & Industry Assistance (SBIA) http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia A Comprehensive Resource for Information on Human Drug Development in Regulation Fri, 12 Aug 2022 14:21:44 EDT FDA http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia Best Practices for Topical Generic Product Development and ANDA Submission - 08/11/2022 http://www.fda.gov/drugs/news-events-human-drugs/best-practices-topical-generic-product-development-and-anda-submission-08112022 Best Practices for Topical Generic Product Development and ANDA Submission Fri, 12 Aug 2022 14:17:19 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/best-practices-topical-generic-product-development-and-anda-submission-08112022 What's New Related to Drugs 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. Fri, 12 Aug 2022 14:10:32 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Calendar of Upcoming Events http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/calendar-upcoming-events Calendar of Upcoming Events Fri, 12 Aug 2022 11:35:49 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/calendar-upcoming-events CDER Manual of Policies & Procedures | MAPP 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. Fri, 12 Aug 2022 11:06:11 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp Notify FDA of Illegitimate Products http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products The Drug Supply Chain Security Act (DSCSA) requires certain trading partners - manufacturers, repackagers, wholesale distributors, and dispensers to notify FDA and all appropriate immediate trading partners within 24-hours after determining a product is illegitimate. Additionally, manufacturers are Fri, 12 Aug 2022 10:50:49 EDT FDA http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products Generic Drug Facilities, Sites and Organization Lists http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Fri, 12 Aug 2022 10:48:42 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists November 16, 2017: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement - 11/15/2017 http://www.fda.gov/advisory-committees/advisory-committee-calendar/november-16-2017-meeting-antimicrobial-drugs-advisory-committee-meeting-announcement-11152017 November 16, 2017: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement Fri, 12 Aug 2022 10:44:27 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/november-16-2017-meeting-antimicrobial-drugs-advisory-committee-meeting-announcement-11152017 First Generic Drug Approvals http://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients. “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. Fri, 12 Aug 2022 10:24:52 EDT FDA http://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals Oncology (Cancer) / Hematologic Malignancies Approval Notifications http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications Oncology (Cancer) / Hematologic Malignancies Approval Notifications Thu, 11 Aug 2022 18:06:05 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer Thu, 11 Aug 2022 18:02:13 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring http://www.fda.gov/consumers/consumer-updates/products-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring Removing moles and other growths on our skin isn’t a DIY project, and can be dangerous to try. There are no FDA-approved drugs for treating moles, seborrheic keratoses, or skin tags. But there are potentially dangerous products being sold claiming to help remove these lesions. Avoid these products. Thu, 11 Aug 2022 16:27:00 EDT FDA http://www.fda.gov/consumers/consumer-updates/products-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring FDA Approves First Targeted Therapy for HER2-Low Breast Cancer http://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer FDA Approves First Targeted Therapy for HER2-Low Breast Cancer Thu, 11 Aug 2022 16:16:47 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer Liver Toxicity Knowledge Base (LTKB) http://www.fda.gov/science-research/bioinformatics-tools/liver-toxicity-knowledge-base-ltkb Overview of the Liver Toxicity Knowledge Base project at the FDA's National Center for Toxicological Research to study drug-induced liver injury (DILI) with links to the LTKB Dataset and DILIrank Dataset, references, and contact information for questions, suggestions, or technical support. Thu, 11 Aug 2022 15:54:49 EDT FDA http://www.fda.gov/science-research/bioinformatics-tools/liver-toxicity-knowledge-base-ltkb Table of Pharmacogenomic Biomarkers in Drug Labeling http://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers. Thu, 11 Aug 2022 14:38:29 EDT FDA http://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling