http://www.fda.gov/ en 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. Sat, 10 Jun 2023 00:02:08 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers. Fri, 09 Jun 2023 16:09:30 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Fri, 09 Jun 2023 16:03:57 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions http://www.fda.gov/news-events/press-announcements/fda-roundup-june-9-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 09 Jun 2023 15:27:08 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-9-2023 http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information Drug Shortages: Additional News and Information Fri, 09 Jun 2023 14:22:28 EDT FDA http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information 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, 09 Jun 2023 14:15:54 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nalpropion-pharmaceuticals-llc-610942-05102023 False & Misleading Claims/Misbranded Fri, 09 Jun 2023 12:26:17 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nalpropion-pharmaceuticals-llc-610942-05102023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/currax-pharmaceuticals-llc-610942-09222020 False & Misleading Claims/Misbranded Fri, 09 Jun 2023 12:23:00 EDT Office of Prescription Drug Promotion http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/currax-pharmaceuticals-llc-610942-09222020 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nalpropion-pharmaceuticals-llc-09222020 False & Misleading Claims/Misbranded Fri, 09 Jun 2023 12:22:59 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nalpropion-pharmaceuticals-llc-09222020 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, 09 Jun 2023 11:52:44 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists 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, 09 Jun 2023 10:29:51 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-controlled-correspondence-enhancements Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or concerning certain post-approval submission requirements. Fri, 09 Jun 2023 10:04:55 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-controlled-correspondence-enhancements http://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan The FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program. Fri, 09 Jun 2023 10:01:53 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan http://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy Checking a pharmacy’s license through your state board of pharmacy is an important step in knowing whether you are using a safe online pharmacy. Thu, 08 Jun 2023 14:34:43 EDT FDA http://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy http://www.fda.gov/drugs/news-events-human-drugs/2023-financial-transparency-and-efficiency-prescription-drug-user-fee-act-biosimilar-user-fee-act The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” Thu, 08 Jun 2023 14:13:57 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/2023-financial-transparency-and-efficiency-prescription-drug-user-fee-act-biosimilar-user-fee-act http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell FDA has approved Epkinly (epcoritamab-bysp) injection for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma after two or more lines of systemic the Thu, 08 Jun 2023 14:06:50 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell http://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-generic-drug-user-fee-amendments-2022 Guidance for Industry Thu, 08 Jun 2023 13:35:11 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-generic-drug-user-fee-amendments-2022 http://www.fda.gov/industry/prescription-drug-user-fee-amendments/condition-specific-meeting-reports-and-other-information-related-patients-experience This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful. Thu, 08 Jun 2023 13:23:56 EDT FDA http://www.fda.gov/industry/prescription-drug-user-fee-amendments/condition-specific-meeting-reports-and-other-information-related-patients-experience http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. Thu, 08 Jun 2023 11:44:20 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp E6(R3) GOOD CLINICAL PRACTICE (GCP) Thu, 08 Jun 2023 11:00:22 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp