http://www.fda.gov/ en http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what&#039;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. Mon, 17 May 2021 14:03:40 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security Drug Supply Chain Security Act pilot project program and enhanced drug distribution security Mon, 17 May 2021 13:45:22 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security 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. Mon, 17 May 2021 13:33:40 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-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 Mon, 17 May 2021 13:28:39 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/news-events/fda-voices/advancing-fdas-mission-targeting-key-areas-regulatory-science-investment-and-innovation The FARS Report communicates the importance and impact of the FDA’s regulatory science research activities and identifies cross-cutting areas that need sustained or new investment to fulfill the FDA’s mission. Mon, 17 May 2021 12:47:18 EDT FDA http://www.fda.gov/news-events/fda-voices/advancing-fdas-mission-targeting-key-areas-regulatory-science-investment-and-innovation http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA&#039;s current thinking on a particular subject. New guidance documents are listed here for three months. Mon, 17 May 2021 11:41:38 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public Mon, 17 May 2021 11:37:33 EDT FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 http://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacturing-supply-chain-and-drug-and-biological-product-inspections-during-covid-19-public-health Manufacturing, Supply Chain, and Drug and Biological Product ...Q&amp;A<br /> Covid-19 Mon, 17 May 2021 11:33:51 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacturing-supply-chain-and-drug-and-biological-product-inspections-during-covid-19-public-health http://www.fda.gov/drugs/medication-health-fraud/public-notification-1-day-diet-contains-hidden-drug-ingredient The Food and Drug Administration (FDA) is advising consumers not to purchase or use “1 Day Diet,” a product promoted and sold for weight loss on various websites and possibly in some retail stores. Mon, 17 May 2021 10:31:14 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/public-notification-1-day-diet-contains-hidden-drug-ingredient http://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-master-protocols-evaluating-drugs-and-biological-products-treatment-or-prevention COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Mon, 17 May 2021 09:06:14 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-master-protocols-evaluating-drugs-and-biological-products-treatment-or-prevention http://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-treatment-adults-serious-rare-blood-disease FDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. Empaveli is the first PNH treatment that binds to compliment protein C3. Fri, 14 May 2021 16:34:14 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-treatment-adults-serious-rare-blood-disease http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-14-2021 Coronavirus (COVID-19) Update: May 14, 2021 Fri, 14 May 2021 16:18:32 EDT FDA http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-14-2021 http://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/2021-meeting-materials-oncologic-drugs-advisory-committee This page contains the meeting materials for the Oncologic Drugs Advisory Committee meetings for 2021, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript. Fri, 14 May 2021 11:29:57 EDT FDA http://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/2021-meeting-materials-oncologic-drugs-advisory-committee http://www.fda.gov/about-fda/fda-history/history-drug-regulation Resources on the history of FDA&#039;s regulation of drugs Fri, 14 May 2021 11:27:35 EDT FDA http://www.fda.gov/about-fda/fda-history/history-drug-regulation http://www.fda.gov/drugs/generic-drugs/fy2020-gdufa-science-and-research-report The Generic Drug User Fee Amendments (GDUFA) established a research program that is implemented through extensive collaborations both within and outside FDA. Fri, 14 May 2021 10:32:05 EDT FDA http://www.fda.gov/drugs/generic-drugs/fy2020-gdufa-science-and-research-report http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements FDA Drug Alerts and Statements Fri, 14 May 2021 10:00:29 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/activities-report-generic-drugs-program-fy-2021-monthly-performance Activities Report of the Generic Drugs Program (FY 2021) Monthly Performance Fri, 14 May 2021 08:47:12 EDT FDA http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/activities-report-generic-drugs-program-fy-2021-monthly-performance http://www.fda.gov/about-fda/national-center-toxicological-research/nctr-annual-reports NCTR Annual Reports (Research Accomplishments and Plans) including the 2015-2016, 2016-2017, 2018, 2019, and 2020 Annual Reports in PDF format. This report summarizes the key accomplishments for each Research Division for the calendar year as well as the Division&#039;s plans for the upcoming year. Thu, 13 May 2021 17:07:58 EDT FDA http://www.fda.gov/about-fda/national-center-toxicological-research/nctr-annual-reports http://www.fda.gov/regulatory-information/search-fda-guidance-documents/submissions-postapproval-modifications-combination-product-approved-under-bla-nda-or-pma Draft guidance for industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Thu, 13 May 2021 15:48:24 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/submissions-postapproval-modifications-combination-product-approved-under-bla-nda-or-pma http://www.fda.gov/advisory-committees/advisory-committee-calendar/april-27-29-2021-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04272021-04292021 April 27-29, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement Thu, 13 May 2021 14:58:44 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/april-27-29-2021-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04272021-04292021