http://www.fda.gov/ en http://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations. Thu, 09 May 2024 16:19:30 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa http://www.fda.gov/drugs/guidances-drugs/withdrawn-expired-guidances Withdrawn and Expired Guidances Thu, 09 May 2024 15:48:40 EDT FDA http://www.fda.gov/drugs/guidances-drugs/withdrawn-expired-guidances http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Thu, 09 May 2024 14:18:46 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024 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, 09 May 2024 14:12:01 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs 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. Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approv Thu, 09 May 2024 14:00:08 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots 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. Thu, 09 May 2024 13:53:22 EDT FDA http://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023 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 Thu, 09 May 2024 13:52:43 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rystiggo Drug Trials Snapshots: RYSTIGGO Thu, 09 May 2024 13:47:59 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rystiggo 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, 09 May 2024 13:33:00 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/regulatory-science-action/whats-new-regulatory-science A newsletter on regulatory science for CDER's stakeholders Thu, 09 May 2024 12:09:00 EDT FDA http://www.fda.gov/drugs/regulatory-science-action/whats-new-regulatory-science http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act. Thu, 09 May 2024 12:05:45 EDT FDA http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals http://www.fda.gov/industry/generic-drug-user-fee-amendments/activities-report-generic-drug-program-fdara-title-viii-sections-807-and-805 Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 Thu, 09 May 2024 11:36:50 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/activities-report-generic-drug-program-fdara-title-viii-sections-807-and-805 http://www.fda.gov/about-fda/oncology-center-excellence/project-orbis Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners. Thu, 09 May 2024 11:05:08 EDT FDA http://www.fda.gov/about-fda/oncology-center-excellence/project-orbis http://www.fda.gov/drugs/news-events-human-drugs/osis-workshop-cder-bioavailabilitybioequivalence-study-sites-and-inspections-good-laboratory OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice Thu, 09 May 2024 09:54:49 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/osis-workshop-cder-bioavailabilitybioequivalence-study-sites-and-inspections-good-laboratory http://www.fda.gov/consumers/consumer-updates/drugs Consumer articles about over-the-counter and prescription drugs. Thu, 09 May 2024 09:54:19 EDT FDA http://www.fda.gov/consumers/consumer-updates/drugs http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Thu, 09 May 2024 09:50:02 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/consumers/consumer-updates/tips-stay-safe-sun-sunscreen-sunglasses Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. The FDA continues to evaluate sunscreen products to ensure that their active ingredients are safe and effective. Thu, 09 May 2024 09:37:08 EDT FDA http://www.fda.gov/consumers/consumer-updates/tips-stay-safe-sun-sunscreen-sunglasses http://www.fda.gov/consumers/consumer-updates/should-you-put-sunscreen-infants-not-usually Your infant’s sensitive skin is vulnerable to serious burns. But sunscreen isn’t the answer. Infants are at greater risk than adults of sunscreen side effects, such as a rash. The FDA recommends keeping newborns and babies younger than 6 months out of direct sunlight. Thu, 09 May 2024 09:26:49 EDT FDA http://www.fda.gov/consumers/consumer-updates/should-you-put-sunscreen-infants-not-usually 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, 09 May 2024 08:44:43 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data-archive-cdrh http://www.fda.gov/drugs/news-events-human-drugs/switching-between-biosimilars-and-their-reference-counterparts-dr-sarah-yim Listen to our latest podcast series, Q&A with FDA, on Switching Between Biosimilars and Their Reference Counterparts, featuring Dr. Sarah Yim. Wed, 08 May 2024 16:39:34 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/switching-between-biosimilars-and-their-reference-counterparts-dr-sarah-yim