What's New: Drugs RSS Feed http://www.fda.gov/ en User Fee 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. Sat, 10 Jun 2023 00:02:08 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists CDERLearn Training and Education 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 Compounding: Inspections, Recalls, and other Actions 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 FDA Roundup: June 9, 2023 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 Drug Shortages | Additional News and Information 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 What's New Related to Drugs 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 Nalpropion Pharmaceuticals LLC - 610942 - 05/10/2023 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 Currax Pharmaceuticals LLC - 610942 - 09/22/2020 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 Nalpropion Pharmaceuticals LLC - 09/22/2020 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 Generic Drug Facilities, Sites and Organization 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, 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 We Are Hiring 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 GDUFA III Controlled Correspondence Enhancements 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 FDA Drug Competition Action Plan 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 Locate a State-Licensed Online Pharmacy 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 2023 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/08/2023 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 FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma 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 Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 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 Condition-Specific Meeting Reports and Other Information Related to Patients' Experience 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 Newly Added Guidance Documents 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 E6(R3) GOOD CLINICAL PRACTICE (GCP) 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