http://www.fda.gov/ en 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, 01 Mar 2024 16:43:18 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-under-section-510j3-fdc-act Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Fri, 01 Mar 2024 16:14:46 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-under-section-510j3-fdc-act http://www.fda.gov/news-events/press-announcements/fda-roundup-march-1-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Mar 2024 15:58:34 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-1-2024 http://www.fda.gov/about-fda/2023-oce-annual-report/ongoing-clinical-oncology-projects Clinical projects of the Oncology Center of Excellence, 2023 Annual Report Fri, 01 Mar 2024 15:47:17 EST FDA http://www.fda.gov/about-fda/2023-oce-annual-report/ongoing-clinical-oncology-projects http://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-mitigation-efforts The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19. Fri, 01 Mar 2024 14:29:50 EST FDA http://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-mitigation-efforts http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Fri, 01 Mar 2024 14:26:12 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications On March 1, 2024, the FDAapproved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Fri, 01 Mar 2024 14:03:01 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications 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). Fri, 01 Mar 2024 14:02:11 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Fri, 01 Mar 2024 13:34:53 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals http://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication. Fri, 01 Mar 2024 13:34:02 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals 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 Mar 2024 11:19:17 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-investigational-drug-or-biologic Emergency Use of an Investigational Drug or Biologic - guidance Fri, 01 Mar 2024 11:08:41 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-investigational-drug-or-biologic http://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees Human Drug Compounding Outsourcing Facility Fees Fri, 01 Mar 2024 10:57:42 EST FDA http://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Fri, 01 Mar 2024 10:57:13 EST FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-drugs-advisory-committee-roster This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee. Fri, 01 Mar 2024 10:09:31 EST FDA http://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-drugs-advisory-committee-roster http://www.fda.gov/drugs/news-events-human-drugs News & Events for Human Drugs Fri, 01 Mar 2024 10:06:38 EST FDA http://www.fda.gov/drugs/news-events-human-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, 01 Mar 2024 10:01:55 EST 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/fda-works-make-informed-consent-easier-understand FDA and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.” Fri, 01 Mar 2024 09:33:20 EST FDA http://www.fda.gov/news-events/fda-voices/fda-works-make-informed-consent-easier-understand http://www.fda.gov/drugs/news-events-human-drugs/qa-fda “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, 01 Mar 2024 07:14:31 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/qa-fda http://www.fda.gov/drugs/spotlight-cder-science/sociodemographic-characteristics-adverse-event-reporting Researchers in CDER’s Office of Surveillance and Epidemiology and others examined the sociodemographic characteristics of individuals who submit FAERS reports Thu, 29 Feb 2024 16:55:20 EST FDA http://www.fda.gov/drugs/spotlight-cder-science/sociodemographic-characteristics-adverse-event-reporting