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. Fri, 02 Jun 2023 18:07:32 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonclinical-evaluation-immunotoxic-potential-pharmaceuticals Pharmacology / Toxicology Fri, 02 Jun 2023 18:03:36 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonclinical-evaluation-immunotoxic-potential-pharmaceuticals http://www.fda.gov/regulatory-information/search-fda-guidance-documents/interstitial-cystitisbladder-pain-syndrome-establishing-drug-development-programs-treatment Draft Guidance Clinical / Medical Fri, 02 Jun 2023 18:03:22 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/interstitial-cystitisbladder-pain-syndrome-establishing-drug-development-programs-treatment http://www.fda.gov/drugs/news-events-human-drugs/fda-cder-nih-ncats-regulatory-fitness-rare-disease-clinical-trials-workshop-05162022 On May 16 and 17, 2022, the FDA’s Center for Drug Evaluation and Research (CDER) and NIH’s National Center for Advancing Translational Sciences (NCATS) will host a jointly sponsored virtual workshop to explore regulatory fitness in rare disease clinical trials. Fri, 02 Jun 2023 16:37:51 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-cder-nih-ncats-regulatory-fitness-rare-disease-clinical-trials-workshop-05162022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/perfect-choice-trading-inc-and-nutricos-ceuticals-inc-569322-06112019 CGMP/Dietary Supplement/Adulterated/Misbranded<br /> Fri, 02 Jun 2023 15:52:05 EDT Center for Drug Evaluation and Research http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/perfect-choice-trading-inc-and-nutricos-ceuticals-inc-569322-06112019 http://www.fda.gov/news-events/press-announcements/fda-roundup-june-2-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 02 Jun 2023 15:45:56 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-2-2023 http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA&#039;s current thinking on a particular subject. New guidance documents are listed here for three months. Fri, 02 Jun 2023 15:29:38 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents 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, 02 Jun 2023 15:28:20 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/guidances-drugs/withdrawnexpired-guidances-drugs Withdrawn/Expired Guidances (Drugs) Fri, 02 Jun 2023 15:22:47 EDT FDA http://www.fda.gov/drugs/guidances-drugs/withdrawnexpired-guidances-drugs http://www.fda.gov/industry/fda-user-fee-programs/gdufa-type-ii-api-dmf-payment-receipts-report GDUFA Type II API DMF Payment Receipts Report Fri, 02 Jun 2023 14:40:28 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/gdufa-type-ii-api-dmf-payment-receipts-report http://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-drug-interaction-assessment-therapeutic-proteins-guidance-industry Clinical Pharmacology Fri, 02 Jun 2023 14:35:09 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-drug-interaction-assessment-therapeutic-proteins-guidance-industry 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, 02 Jun 2023 14:17:55 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents 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, 02 Jun 2023 13:36:46 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, 02 Jun 2023 13:32:46 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/drugs/cder-foia-electronic-reading-room/frequently-requested-or-proactively-posted-compliance-records Frequently requested inspection records of foreign pharmaceutical manufacturing facilities Fri, 02 Jun 2023 13:02:02 EDT FDA http://www.fda.gov/drugs/cder-foia-electronic-reading-room/frequently-requested-or-proactively-posted-compliance-records http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-applied-regulatory-science The Division of Applied Regulatory Science is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and develops and implements new regulatory review tools and approaches. Fri, 02 Jun 2023 12:02:53 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-applied-regulatory-science http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol Fri, 02 Jun 2023 11:29:16 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Fri, 02 Jun 2023 11:13:09 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions http://www.fda.gov/news-events/public-health-focus/fda-and-kratom The U.S. Food and Drug Administration is warning consumers not to use &lt;i&gt;Mitragyna speciosa&lt;/i&gt;, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence. Fri, 02 Jun 2023 10:30:39 EDT FDA http://www.fda.gov/news-events/public-health-focus/fda-and-kratom http://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-metrics-drug-manufacturing Quality Metrics Data Reporting: This program will help FDA to address common quality issues in the pharmaceutical industry, address product shortage issues, and encourage modernization of pharmaceutical manufacturing. Fri, 02 Jun 2023 10:11:22 EDT FDA http://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-metrics-drug-manufacturing