http://www.fda.gov/ en http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications Oncology (Cancer) / Hematologic Malignancies Approval Notifications Fri, 01 Dec 2023 17:56:47 EST 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&#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. Fri, 01 Dec 2023 17:06:07 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 Innovative drugs often mean new treatment options for patients and advances in health care for the American public. Fri, 01 Dec 2023 16:49:24 EST FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent. Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approv Fri, 01 Dec 2023 16:48:53 EST FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Dec 2023 16:46:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 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, 01 Dec 2023 16:21:31 EST FDA http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities 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, 01 Dec 2023 15:47:59 EST 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 Fri, 01 Dec 2023 15:38:04 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems The iPLEDGE REMS was originally implemented in early 2005. The goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. It is a “shared system” REMS, meaning that it incl Fri, 01 Dec 2023 15:21:47 EST FDA http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-ipledge-rems Questions and Answers on the iPLEDGE REMS Fri, 01 Dec 2023 14:50:06 EST FDA http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-ipledge-rems 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 Fri, 01 Dec 2023 14:29:15 EST 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/safety/recalls-market-withdrawals-safety-alerts/uvt-inc-issues-voluntary-nationwide-recall-saniderm-advanced-hand-sanitizer-due-potential-presence UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)<br /> Fri, 01 Dec 2023 08:49:06 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/uvt-inc-issues-voluntary-nationwide-recall-saniderm-advanced-hand-sanitizer-due-potential-presence http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/professional-compounding-centers-america-dba-pcca-597638-11212023 CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Fri, 01 Dec 2023 07:20:23 EST FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/professional-compounding-centers-america-dba-pcca-597638-11212023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/professional-compounding-centers-america-dba-pcca-597638-01272021 CGMP/Finished Pharmaceuticals/Adulterated/Misbranded<br /> Fri, 01 Dec 2023 07:20:08 EST Center for Drug Evaluation and Research http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/professional-compounding-centers-america-dba-pcca-597638-01272021 http://www.fda.gov/drugs/news-events-human-drugs/online-controlled-substances-summits FDA hosted its fourth summit on June 8, 2023, as an integral part of FDA’s overall efforts to protect the public, including youth, from harm associated with drugs that have abuse potential. Thu, 30 Nov 2023 16:22:43 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/online-controlled-substances-summits http://www.fda.gov/drugs/news-events-human-drugs/new-approaches-integrated-nonclinical-clinical-qtproarrhythmic-risk-assessment-10152020 New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment Thu, 30 Nov 2023 16:13:49 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/new-approaches-integrated-nonclinical-clinical-qtproarrhythmic-risk-assessment-10152020 http://www.fda.gov/drugs/news-events-human-drugs/improving-implementation-risk-based-monitoring-approaches-clinical-investigations Meeting Thu, 30 Nov 2023 16:02:15 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/improving-implementation-risk-based-monitoring-approaches-clinical-investigations http://www.fda.gov/drugs/news-events-human-drugs/more-spotlight-cder-science-articles FDA scientists carry out laboratory, clinical and analytical research to address knowledge gaps in drug development, healthcare technologies and post-market drug monitoring. Spotlight on CDER Science features noteworthy scientific and research-oriented activities conducted within CDER. Thu, 30 Nov 2023 15:54:41 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/more-spotlight-cder-science-articles http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-product-tracing-requirements-frequently-asked-questions Drug Supply Chain Security Act Product Tracing Requirements Frequently Asked Questions Thu, 30 Nov 2023 15:08:46 EST FDA http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-product-tracing-requirements-frequently-asked-questions 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 Thu, 30 Nov 2023 14:47:11 EST FDA http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia