http://www.fda.gov/ en http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol Tue, 23 Apr 2024 06:45:49 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use http://www.fda.gov/about-fda/user-fee-performance-reports/pdufa-performance-reports PDUFA Performance Reports Mon, 22 Apr 2024 22:37:26 EDT FDA http://www.fda.gov/about-fda/user-fee-performance-reports/pdufa-performance-reports http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papilla Mon, 22 Apr 2024 18:13:55 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC). Mon, 22 Apr 2024 18:11:22 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications 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. Mon, 22 Apr 2024 18:11:17 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-development-considerations-empiric-antibacterial-therapy-febrile-neutropenic-patients-04232024 The purpose of the public workshop is to discuss clinical trial design and other considerations related to the development of antibacterial drug products for treatment of febrile neutropenia (FN). Mon, 22 Apr 2024 17:13:48 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/drug-development-considerations-empiric-antibacterial-therapy-febrile-neutropenic-patients-04232024 http://www.fda.gov/drugs/compounding-quality-center-excellence/compounding-quality-center-excellence-annual-conference Compounding Quality Center of Excellence Virtual Conference Mon, 22 Apr 2024 16:13:32 EDT FDA http://www.fda.gov/drugs/compounding-quality-center-excellence/compounding-quality-center-excellence-annual-conference http://www.fda.gov/drugs/news-events-human-drugs/2024-compounding-quality-center-excellence-annual-conference-08212024 The FDA Compounding Quality Center of Excellence will host its fifth Annual Conference, Aug. 21-23. This hybrid event provides an opportunity for outsourcing facilities and others to learn and build networks to help the industry improve the quality of compounded drugs for patients who need them. Mon, 22 Apr 2024 16:12:52 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/2024-compounding-quality-center-excellence-annual-conference-08212024 http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-naloxone-and-nalmefene The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the availability, accessibility, and development of novel overdose reversal drugs, including naloxone and nalmefene. Mon, 22 Apr 2024 14:25:37 EDT FDA http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-naloxone-and-nalmefene http://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations. Mon, 22 Apr 2024 14:04:41 EDT FDA http://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot http://www.fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance One way FDA works to ensure drug manufacturers comply with Current Good Manufacturing Practice (CGMP) requirements is through inspections. Learn more about actions that can be taken if manufacturers fail to meet CGMP regulatory standards. Mon, 22 Apr 2024 13:34:39 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance 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 Mon, 22 Apr 2024 13:15:38 EDT FDA http://www.fda.gov/drugs/science-and-research-drugs/regulatory-science-action http://www.fda.gov/drugs/news-events-human-drugs/redesigned-pre-submission-meetings-gdufa-iii-benefits-anda-submission-and-approval-05092024 Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval Mon, 22 Apr 2024 11:08:35 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/redesigned-pre-submission-meetings-gdufa-iii-benefits-anda-submission-and-approval-05092024 http://www.fda.gov/news-events/fda-voices/reflections-travel-europe-part-two I recently had the privilege of official travel to the U.K. with our global affairs team. Mon, 22 Apr 2024 09:49:53 EDT FDA http://www.fda.gov/news-events/fda-voices/reflections-travel-europe-part-two 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, 22 Apr 2024 09:32:38 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-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. Mon, 22 Apr 2024 09:28:46 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/news-events/fda-voices/reflections-travel-europe-part-one I recently had the privilege of official travel to the U.K. and European Union with our global affairs team. Mon, 22 Apr 2024 09:26:28 EDT FDA http://www.fda.gov/news-events/fda-voices/reflections-travel-europe-part-one http://www.fda.gov/drugs/news-events-human-drugs/drug-development-considerations-treatment-congenital-cytomegalovirus-infection-and-neonatal The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection. Fri, 19 Apr 2024 16:25:25 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/drug-development-considerations-treatment-congenital-cytomegalovirus-infection-and-neonatal http://www.fda.gov/news-events/press-announcements/fda-roundup-april-19-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 19 Apr 2024 16:19:55 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-19-2024 http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Fri, 19 Apr 2024 15:38:39 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer