http://www.fda.gov/ en http://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process. Fri, 05 May 2023 11:09:06 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments 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, 05 May 2023 10:49:39 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Fri, 05 May 2023 10:09:39 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/about-fda/nctr-publications/2018-nctr-research-highlights 2018 NCTR Research Highlights and Accomplishments: Biomarkers, BEST Resource, Antimicrobial-Resistance Research, Cancer Research at NCTR, Neuroscience News, Improving Understanding of Liver Toxicity, and more. Subscribe to e-mail notifications. Fri, 05 May 2023 10:08:14 EDT FDA http://www.fda.gov/about-fda/nctr-publications/2018-nctr-research-highlights http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. Thu, 04 May 2023 16:40:26 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-prescription-drug-user-fee-amendments-2022 This guidance provides information to stakeholders regarding EFDA’s implementation of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) under Title I of The FDA User Fee Reauthorization Act of 2022. Thu, 04 May 2023 14:34:08 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-prescription-drug-user-fee-amendments-2022 http://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and-0 This page contains the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster, which lists the current members and the current number of vacancies for the committee. Thu, 04 May 2023 14:13:12 EDT FDA http://www.fda.gov/advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and-0 http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information Drug Shortages: Additional News and Information Thu, 04 May 2023 14:08:41 EDT FDA http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w Thu, 04 May 2023 13:26:50 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry http://www.fda.gov/drugs/news-events-human-drugs/public-webinar-patient-focused-drug-development-incorporating-clinical-outcome-assessments-endpoints On May 4, 2023, the U.S. Food and Drug Administration (FDA) is hosting a webinar for patients, industry, and other interested stakeholders to discuss and answer questions about the draft guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints Thu, 04 May 2023 13:16:30 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/public-webinar-patient-focused-drug-development-incorporating-clinical-outcome-assessments-endpoints http://www.fda.gov/drugs/medication-health-fraud/diamond-girl-lite-contains-hidden-drug-ingredient The Food and Drug Administration is advising consumers not to purchase or use Diamond Girl Lite, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Thu, 04 May 2023 11:41:37 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/diamond-girl-lite-contains-hidden-drug-ingredient http://www.fda.gov/drugs/medication-health-fraud/tainted-sexual-enhancement-products Sexual enhancement products sold over the counter may contain hidden drugs that could be harmful. Buyers should use caution. There is a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are usually promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories. Thu, 04 May 2023 11:37:04 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tainted-sexual-enhancement-products http://www.fda.gov/drugs/medication-health-fraud/special-edition-platinum-10k-contains-hidden-drug-ingredients The Food and Drug Administration is advising consumers not to purchase or use Special Edition Platinum 10K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Thu, 04 May 2023 11:35:17 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/special-edition-platinum-10k-contains-hidden-drug-ingredients http://www.fda.gov/drugs/medication-health-fraud/hard-steel-300k-contains-hidden-drug-ingredients The Food and Drug Administration is advising consumers not to purchase or use Hard Steel 300K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Thu, 04 May 2023 11:30:31 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/hard-steel-300k-contains-hidden-drug-ingredients http://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present). Thu, 04 May 2023 11:15:40 EDT FDA http://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages http://www.fda.gov/industry/fda-user-fee-programs/gdufa-type-ii-api-dmf-payment-receipts-report GDUFA Type II API DMF Payment Receipts Report Thu, 04 May 2023 11:13:25 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/gdufa-type-ii-api-dmf-payment-receipts-report http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/family-dollar-initiating-voluntary-recall-certain-over-counter-drug-products-because-products-have Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by Family Thu, 04 May 2023 11:00:52 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/family-dollar-initiating-voluntary-recall-certain-over-counter-drug-products-because-products-have 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, 04 May 2023 09:30:23 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-naloxone Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. In the wake of the opioid epidemic, efforts are underway to make this emergency treatment more readily available and more accessible. Thu, 04 May 2023 06:55:41 EDT FDA http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-naloxone http://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development Digital Health Technologies (DHTs) for Drug Development Wed, 03 May 2023 18:43:49 EDT FDA http://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development