What's New: Drugs RSS Feed http://www.fda.gov/ en Study Data Standards Resources http://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources Study Data Standards Resources Fri, 03 Feb 2023 18:17:35 EST FDA http://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources Antimicrobial Resistance Information from FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR. Fri, 03 Feb 2023 17:17:34 EST FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda Endocrinologic and Metabolic Drugs Advisory Committee Roster http://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-roster Advisory Committees (Drugs) Fri, 03 Feb 2023 16:28:37 EST FDA http://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-roster 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, 03 Feb 2023 16:16:29 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs GDUFA III Controlled Correspondence Enhancements http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-controlled-correspondence-enhancements Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or concerning certain post-approval submission requirements. Fri, 03 Feb 2023 16:08:03 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-controlled-correspondence-enhancements A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence - 03/14/2023 http://www.fda.gov/drugs/news-events-human-drugs/deep-dive-fda-draft-guidance-statistical-approaches-establishing-bioequivalence-03142023 Webinar will take a deeper look into the draft guidance for new and revised content and provide clarification to comments received through the public docket. Fri, 03 Feb 2023 16:05:46 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/deep-dive-fda-draft-guidance-statistical-approaches-establishing-bioequivalence-03142023 FDA/CRCG Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products - 04/20/2023 http://www.fda.gov/drugs/news-events-human-drugs/fdacrcg-considerations-and-alternatives-comparative-clinical-endpoint-and-pharmacodynamic FDA recommendations for establishing bioequivalence (BE) with local drug delivery for orally inhaled drug products (OIDPs) often involve study designs for conducting comparative clinical endpoint (CCEP) and pharmacodynamic (PD) BE studies. Fri, 03 Feb 2023 15:12:03 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/fdacrcg-considerations-and-alternatives-comparative-clinical-endpoint-and-pharmacodynamic Electronic Registration and Listing Compliance Program http://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-registration-and-listing-compliance-program Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL). Fri, 03 Feb 2023 14:51:04 EST FDA http://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-registration-and-listing-compliance-program US-Canada Regional ICH Consultation - 05/11/2022 http://www.fda.gov/drugs/news-events-human-drugs/us-canada-regional-ich-consultation-05112022 FDA and Health Canada will be co-hosting a regional public meeting to provide information and solicit input prior to the next ICH biannual Assembly and Management Committee meetings scheduled for May 21 - 25, 2022. Fri, 03 Feb 2023 14:16:55 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/us-canada-regional-ich-consultation-05112022 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, 03 Feb 2023 13:20:17 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention http://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse Fri, 03 Feb 2023 13:19:48 EST FDA http://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose 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, 03 Feb 2023 13:16:25 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 http://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological CDER Scientific Reviews Supporting EUA for Therapeutic Products Fri, 03 Feb 2023 11:59:33 EST FDA http://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological OTC Drug Review Process | OTC Drug Monographs http://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. Fri, 03 Feb 2023 11:56:47 EST FDA http://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act http://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act Information about Over-the-Counter (OTC) Monograph Reform Fri, 03 Feb 2023 11:54:50 EST FDA http://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act 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 Fri, 03 Feb 2023 11:51:29 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications Regulatory Science in Action http://www.fda.gov/drugs/science-and-research-drugs/regulatory-science-action Developing new tools, standards, and approaches to assess drug safety, efficacy, quality, and performance Fri, 03 Feb 2023 11:38:42 EST FDA http://www.fda.gov/drugs/science-and-research-drugs/regulatory-science-action Drugs http://www.fda.gov/consumers/consumer-updates/drugs Consumer articles about over-the-counter and prescription drugs. Fri, 03 Feb 2023 11:02:44 EST FDA http://www.fda.gov/consumers/consumer-updates/drugs Generic Drugs Program Activities Report - FY 2022 Monthly Performance http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drugs-program-activities-report-fy-2022-monthly-performance This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications. Data includes approvals, applications received, complete responses, and more. Fri, 03 Feb 2023 10:56:44 EST FDA http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drugs-program-activities-report-fy-2022-monthly-performance Drug Shortages | Additional News and Information http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information Drug Shortages: Additional News and Information Fri, 03 Feb 2023 09:37:38 EST FDA http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information