http://www.fda.gov/ en 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, 29 Dec 2022 17:17:04 EST FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2cr2-periodic-benefit-risk-evaluation-report-questions-and-answers International Conference on Harmonization - Efficacy Thu, 29 Dec 2022 14:18:31 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2cr2-periodic-benefit-risk-evaluation-report-questions-and-answers http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2cr2-periodic-benefit-risk-evaluation-report-pbrer International Council on Harmonisation- Efficacy Thu, 29 Dec 2022 14:12:23 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2cr2-periodic-benefit-risk-evaluation-report-pbrer http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 Innovative drugs often mean new treatment options for patients and advances in health care for the American public. Thu, 29 Dec 2022 12:38:31 EST FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 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 Thu, 29 Dec 2022 11:15:45 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10 Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b Thu, 29 Dec 2022 11:02:09 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10 http://www.fda.gov/drugs/coronavirus-covid-19-drugs/compounding-activities-covid-19 Providing guidance on compounded drugs Thu, 29 Dec 2022 10:55:20 EST FDA http://www.fda.gov/drugs/coronavirus-covid-19-drugs/compounding-activities-covid-19 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. Thu, 29 Dec 2022 09:45:08 EST FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-applied-regulatory-science 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. Thu, 29 Dec 2022 08:27:53 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists 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, 29 Dec 2022 07:53:36 EST FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer Thu, 29 Dec 2022 07:21:14 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin http://www.fda.gov/drugs/human-drug-compounding/safety-risks-associated-certain-bulk-drug-substances-nominated-use-compounding Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act Thu, 29 Dec 2022 00:00:03 EST FDA http://www.fda.gov/drugs/human-drug-compounding/safety-risks-associated-certain-bulk-drug-substances-nominated-use-compounding http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices. Wed, 28 Dec 2022 19:14:47 EST FDA http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling 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. Wed, 28 Dec 2022 14:33:59 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-vancomycin-hydrochloride-injection-usp Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Flip-top Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial. Wed, 28 Dec 2022 13:21:54 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-vancomycin-hydrochloride-injection-usp 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 Wed, 28 Dec 2022 11:01:42 EST FDA http://www.fda.gov/drugs/cder-foia-electronic-reading-room/frequently-requested-or-proactively-posted-compliance-records http://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. Wed, 28 Dec 2022 10:03:21 EST FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding http://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-agenda-information-october-28-2022-meeting-oncologic-drugs-advisory-committee-meeting October 28, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement Tue, 27 Dec 2022 17:19:21 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-agenda-information-october-28-2022-meeting-oncologic-drugs-advisory-committee-meeting http://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers.” The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice Tue, 27 Dec 2022 16:52:47 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gfa-production-xiamen-co-ltd-issues-voluntary-nationwide-recall-easy-care-first-aidr-burn-cream-and Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p Tue, 27 Dec 2022 16:48:19 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gfa-production-xiamen-co-ltd-issues-voluntary-nationwide-recall-easy-care-first-aidr-burn-cream-and