What's New: Drugs RSS Feed http://www.fda.gov/ en 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. Mon, 17 Jun 2024 16:50:55 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs CDERLearn http://www.fda.gov/training-and-continuing-education/cderlearn Training and Education for healthcare professionals, academia, and consumers from FDA’s Center for Drug Evaluation and Research Mon, 17 Jun 2024 16:38:41 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn 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 Mon, 17 Jun 2024 16:30:48 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Food and Drug Administration Overdose Prevention Framework http://www.fda.gov/drugs/drug-safety-and-availability/food-and-drug-administration-overdose-prevention-framework Working across the Agency, FDA’s Overdose Prevention priorities closely align with HHS and bring together our ongoing and proposed activities to strengthen FDA’s role in combatting the drug overdose crisis, including opioids. Mon, 17 Jun 2024 16:27:31 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/food-and-drug-administration-overdose-prevention-framework Supporting Clinical Practice Guidelines for Drugs with Abuse Potential http://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/supporting-clinical-practice-guidelines-drugs-abuse-potential Information regarding the FDA's efforts to support the development of clinical practice guidelines for drugs with abuse potential. Mon, 17 Jun 2024 16:25:03 EDT FDA http://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/supporting-clinical-practice-guidelines-drugs-abuse-potential CDER Small Business and Industry Assistance (SBIA) Learn http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-small-business-and-industry-assistance-sbia-learn SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry. Mon, 17 Jun 2024 15:06:51 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-small-business-and-industry-assistance-sbia-learn New Drug Therapy Approvals 2020 http://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2020 Summary of FDA Center for Drug Evaluation and Research’s approvals of novel drug therapies along with approvals for biosimilars and other new approvals. Mon, 17 Jun 2024 13:53:16 EDT FDA http://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2020 Introduction to FDA’s Office of Trade and Global Partnerships - 07/23/2024 http://www.fda.gov/drugs/news-events-human-drugs/introduction-fdas-office-trade-and-global-partnerships-07232024 Introduction to FDA’s Office of Trade and Global Partnerships Mon, 17 Jun 2024 13:10:20 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/introduction-fdas-office-trade-and-global-partnerships-07232024 List of Determinations Including Written Request http://www.fda.gov/drugs/development-resources/list-determinations-including-written-request In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007. Mon, 17 Jun 2024 13:08:12 EDT FDA http://www.fda.gov/drugs/development-resources/list-determinations-including-written-request Oncology (Cancer) / Hematologic Malignancies Approval Notifications 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). Mon, 17 Jun 2024 12:27:35 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications 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. Mon, 17 Jun 2024 12:14:03 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Expanded Access | Information for Industry http://www.fda.gov/news-events/expanded-access/expanded-access-information-industry Expanded Access information for medical product companies and other industry stakeholders Mon, 17 Jun 2024 12:10:42 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-information-industry Expanded Access | Information for Physicians http://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians Expanded Access: Physicians' Page Mon, 17 Jun 2024 12:10:08 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians Expanded Access (Compassionate Use) Submission Data http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data Expanded Access (Compassionate Use) Submission Data Mon, 17 Jun 2024 12:00:13 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data Where to Send Completed Form FDA 3500A MANDATORY Reporting Form http://www.fda.gov/safety/reporting-serious-problems-fda/where-send-completed-form-fda-3500a-mandatory-reporting-form Where to Send Mandatory Reporting Forms (Pre-Marketing IND Safety and Post-Marketing Reports) Mon, 17 Jun 2024 11:46:31 EDT FDA http://www.fda.gov/safety/reporting-serious-problems-fda/where-send-completed-form-fda-3500a-mandatory-reporting-form Expanded Access | Information for Institutional Review Boards (IRBs) http://www.fda.gov/news-events/expanded-access/expanded-access-information-institutional-review-boards-irbs Learn more about what IRBs should consider when reviewing Individual Patient Expanded Access Requests. Mon, 17 Jun 2024 11:38:04 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-information-institutional-review-boards-irbs 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. Mon, 17 Jun 2024 11:10:11 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Diabetic Foot Infections: Developing Drugs for Treatment http://www.fda.gov/regulatory-information/search-fda-guidance-documents/diabetic-foot-infections-developing-drugs-treatment Diabetic Foot Infections: Developing Drugs for Treatment Mon, 17 Jun 2024 10:53:05 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/diabetic-foot-infections-developing-drugs-treatment Search for Pharmaceutical Quality Documents http://www.fda.gov/drugs/pharmaceutical-quality-resources/search-pharmaceutical-quality-documents FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs in a searchable and filterable table format Mon, 17 Jun 2024 08:45:05 EDT FDA http://www.fda.gov/drugs/pharmaceutical-quality-resources/search-pharmaceutical-quality-documents Facility Readiness: Goal Date Decisions Under GDUFA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/facility-readiness-goal-date-decisions-under-gdufa This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h. Mon, 17 Jun 2024 08:45:04 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/facility-readiness-goal-date-decisions-under-gdufa