http://www.fda.gov/ en 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 http://www.fda.gov/drugs/news-events-human-drugs/drug-development-treatment-congenital-cytomegalovirus-infection-and-neonatal-enterovirus-infection 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 15:13:44 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/drug-development-treatment-congenital-cytomegalovirus-infection-and-neonatal-enterovirus-infection http://www.fda.gov/drugs/news-events-human-drugs/integrated-safety-analyses-drug-marketing-applications-avoiding-common-mistakes-03072024 Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes Fri, 19 Apr 2024 14:55:48 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/integrated-safety-analyses-drug-marketing-applications-avoiding-common-mistakes-03072024 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, 19 Apr 2024 14:17:16 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs 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, 19 Apr 2024 14:09:47 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/compounding-quality-center-excellence/compounding-quality-center-excellence-instructor-led-trainings The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available. Fri, 19 Apr 2024 14:01:13 EDT FDA http://www.fda.gov/drugs/compounding-quality-center-excellence/compounding-quality-center-excellence-instructor-led-trainings http://www.fda.gov/drugs/news-events-human-drugs/expanding-generic-drug-access-through-international-engagements-02282024 Expanding Generic Drug Access Through International Engagements Fri, 19 Apr 2024 12:49:19 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/expanding-generic-drug-access-through-international-engagements-02282024 http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individua Fri, 19 Apr 2024 11:55:42 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring FDA/CDER employment opportunities utilizing the FDA 21st Century Cures Act Hiring Authority Fri, 19 Apr 2024 11:38:54 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-sbia-chronicles FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation Fri, 19 Apr 2024 11:31:16 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-sbia-chronicles 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). Fri, 19 Apr 2024 11:18:21 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/news-events-human-drugs/qa-fda-podcast “Q&A with FDA” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions Fri, 19 Apr 2024 11:18:13 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/qa-fda-podcast http://www.fda.gov/drugs/medication-health-fraud/tainted-weight-loss-products FDA is notifying consumers of certain products promoted for weight loss that have been found to contain hidden ingredients and may pose a significant health risk. Thu, 18 Apr 2024 17:12:45 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tainted-weight-loss-products 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). Thu, 18 Apr 2024 16:55:22 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications http://www.fda.gov/drugs/biosimilars/biosimilars-action-plan FDA is committed to encouraging innovation and competition for biologics and facilitating the development of safe and effective biosimilars. Thu, 18 Apr 2024 14:13:04 EDT FDA http://www.fda.gov/drugs/biosimilars/biosimilars-action-plan http://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information Thu, 18 Apr 2024 13:36:35 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related http://www.fda.gov/drugs/guidance-compliance-regulatory-information Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including nicotine-containing products, human drug compounding, and the Sunscreen Innovation Act. Thu, 18 Apr 2024 12:39:34 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information 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. Thu, 18 Apr 2024 12:37:05 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance http://www.fda.gov/drugs/cder-conversations/patient-medication-information-2023-proposed-rule-help-patients-understand-their-prescription FDA proposed a new type of Medication Guide known as Patient Medication Information (PMI). PMI is designed to provide concise, easy-to-understand information about prescription medicines for patients. Thu, 18 Apr 2024 10:17:29 EDT FDA http://www.fda.gov/drugs/cder-conversations/patient-medication-information-2023-proposed-rule-help-patients-understand-their-prescription http://www.fda.gov/drugs/medication-health-fraud/tainted-arthritis-pain-products FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. Wed, 17 Apr 2024 17:31:34 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tainted-arthritis-pain-products