http://www.fda.gov/ en http://www.fda.gov/drugs/news-events-human-drugs/fdaphuse-computational-science-symposium-06032024 The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and PHUSE agree to co-sponsor the FDA/PHUSE Computational Science Symposium (CSS). This annual meeting brings together FDA, industry and academia to work together in a non-competitive environment to find solutions to shared problems. Fri, 31 May 2024 16:34:32 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fdaphuse-computational-science-symposium-06032024 http://www.fda.gov/drugs/things-know-about/10-things-know-about-cders-pharmaceutical-quality-functions-0 Pharmaceutical quality provides the confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed. Learn more. Fri, 31 May 2024 15:25:15 EDT FDA http://www.fda.gov/drugs/things-know-about/10-things-know-about-cders-pharmaceutical-quality-functions-0 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 31 May 2024 15:21:34 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024 http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e14-clinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic-0 International Council on Harmonisation - Efficacy Fri, 31 May 2024 14:56:21 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e14-clinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic-0 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 Fri, 31 May 2024 14:39:16 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/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development Fri, 31 May 2024 14:38:15 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-05292024 False & Misleading Claims/Misbranded Fri, 31 May 2024 14:07:53 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-05292024 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, 31 May 2024 14:07:39 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/astrazeneca-pharmaceuticals-lp-664789-08042023 False & Misleading Claims/Misbranded Fri, 31 May 2024 14:07:09 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-08042023 http://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023 Each year, CDER approves a wide range of new drugs and biological products. Fri, 31 May 2024 13:58:41 EDT FDA http://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023 http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent. Fri, 31 May 2024 13:55:59 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-ectd The OPDP eCTD page contains all resources and reference materials produced by OPDP in support of the OPDP Electronic Submissions Guidance. Fri, 31 May 2024 13:25:51 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-ectd http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-metrics FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs. Fri, 31 May 2024 13:24:16 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-metrics http://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program End of
Translation FDA's Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading. Fri, 31 May 2024 13:22:11 EDT FDA http://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-regulatory-information OPDP Regulatory Information Fri, 31 May 2024 13:20:29 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-regulatory-information 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, 31 May 2024 13:18:10 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/contact-opdp OPDP Contact information Fri, 31 May 2024 13:18:01 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/contact-opdp http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions-faqs Frequently Asked Questions (FAQs) Fri, 31 May 2024 11:42:12 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions-faqs http://www.fda.gov/drugs/news-events-human-drugs/office-prescription-drug-promotion-opdp-news Review the latest news from the Office of Prescription Drug Promotion. Fri, 31 May 2024 11:38:42 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/office-prescription-drug-promotion-opdp-news 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, 31 May 2024 10:46:28 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring