http://www.fda.gov/ en 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, 16 May 2024 17:40:38 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs 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. Thu, 16 May 2024 16:50:15 EDT FDA http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Thu, 16 May 2024 16:40:18 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals 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, 16 May 2024 16:39:10 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages Drug Shortages homepage Thu, 16 May 2024 16:16:16 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages http://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products Frequently Asked Questions About Therapeutic Biological Products Thu, 16 May 2024 15:52:06 EDT FDA http://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products 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). Thu, 16 May 2024 15:36:59 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications http://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Thu, 16 May 2024 15:33:05 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer 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, 16 May 2024 14:54:23 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn 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. Thu, 16 May 2024 14:45:00 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/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, 16 May 2024 14:03:05 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/drugs/human-drug-compounding/bulk-drug-substances-used-compounding Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding. Thu, 16 May 2024 13:58:41 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding http://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list 503B Bulk Drug Substances List Thu, 16 May 2024 13:08:21 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list 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, 16 May 2024 12:46:49 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements FDA Drug Alerts and Statements Thu, 16 May 2024 12:26:47 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements http://www.fda.gov/drugs/news-events-human-drugs/2024-compounding-quality-center-excellence-annual-conference-08212024 The FDA Compounding Quality Center of Excellence will host its fifth Annual Conference, Aug. 21-23. This hybrid event provides an opportunity for outsourcing facilities and others to learn and build networks to help the industry improve the quality of compounded drugs for patients who need them. Thu, 16 May 2024 11:42:44 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/2024-compounding-quality-center-excellence-annual-conference-08212024 http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-sbia-chronicles FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation Thu, 16 May 2024 11:23:47 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-sbia-chronicles 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. Thu, 16 May 2024 11:03:57 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/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products. Thu, 16 May 2024 09:41:41 EDT FDA http://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development http://www.fda.gov/drugs/buying-using-medicine-safely/counterfeit-medicine Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients. Wed, 15 May 2024 18:57:56 EDT FDA http://www.fda.gov/drugs/buying-using-medicine-safely/counterfeit-medicine