http://www.fda.gov/ en http://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. Thu, 01 Sep 2022 13:25:06 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers. Thu, 01 Sep 2022 12:10:12 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education http://www.fda.gov/news-events/fda-voices/using-whole-governments-approach-combating-illicit-health-products A whole-of-governments approach is the best way to protect the public health from the trade of illicit health products and the FDA will advocate for that approach. Thu, 01 Sep 2022 12:08:37 EDT FDA http://www.fda.gov/news-events/fda-voices/using-whole-governments-approach-combating-illicit-health-products http://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-2022-current-state-generic-drugs-04262022 Presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs Thu, 01 Sep 2022 11:47:18 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-2022-current-state-generic-drugs-04262022 http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data-archive-cdrh Expanded access submission data for 2009 through 2013 Thu, 01 Sep 2022 11:11:12 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data-archive-cdrh 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 Thu, 01 Sep 2022 10:56:49 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/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Thu, 01 Sep 2022 10:15:53 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists 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. Thu, 01 Sep 2022 10:10:06 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements FDA Drug Alerts and Statements Thu, 01 Sep 2022 10:04:57 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-arc-program The mission of CDER’s ARC Program is to drive scientific and regulatory innovation and engagement to accelerate the availability of treatments for patients with rare diseases. Thu, 01 Sep 2022 09:55:04 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-arc-program http://www.fda.gov/drugs/drug-safety-and-availability/fda-initiates-lysosomal-diseases-pre-consortium-critical-path-institute FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce its partnership with the Critical Path Institute (C-Path) to explore the feasibility of launching the Lysosomal Diseases Consortium, a public-private partnership among FDA, leading academic institutions, pharmaceutical indus Thu, 01 Sep 2022 09:53:17 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-initiates-lysosomal-diseases-pre-consortium-critical-path-institute http://www.fda.gov/drugs/generic-drugs/generic-drug-research-related-guidances-reports The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. OGD also publishes an annual research report each fiscal year, summarizing the research activities and outcomes from both extramural and intramural projects. Thu, 01 Sep 2022 09:00:02 EDT FDA http://www.fda.gov/drugs/generic-drugs/generic-drug-research-related-guidances-reports http://www.fda.gov/drugs/guidance-compliance-regulatory-information/center-research-complex-generics FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG). Wed, 31 Aug 2022 13:20:12 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/center-research-complex-generics 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. Wed, 31 Aug 2022 12:53:37 EDT FDA http://www.fda.gov/drugs/development-resources/list-determinations-including-written-request 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. Wed, 31 Aug 2022 11:08:38 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-small-business-and-industry-assistance-sbia-learn http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia A Comprehensive Resource for Information on Human Drug Development in Regulation Wed, 31 Aug 2022 10:50:55 EDT FDA http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia http://www.fda.gov/drugs/news-events-human-drugs/fda-nanoday-symposium-2022-10112022 SBIA conference: FDA NanoDay Symposium 2022 Wed, 31 Aug 2022 10:46:10 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-nanoday-symposium-2022-10112022 http://www.fda.gov/drugs/news-events-human-drugs/best-practices-topical-generic-product-development-and-anda-submission-08112022 Best Practices for Topical Generic Product Development and ANDA Submission Wed, 31 Aug 2022 10:40:54 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/best-practices-topical-generic-product-development-and-anda-submission-08112022 http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data Expanded Access (Compassionate Use) Submission Data Wed, 31 Aug 2022 10:09:31 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data http://www.fda.gov/news-events/fda-voices/fdas-overdose-prevention-framework-aims-prevent-drug-overdoses-and-reduce-death The FDA Overdose Prevention Framework is our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. Wed, 31 Aug 2022 09:29:11 EDT FDA http://www.fda.gov/news-events/fda-voices/fdas-overdose-prevention-framework-aims-prevent-drug-overdoses-and-reduce-death