http://www.fda.gov/ en 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. Fri, 01 Sep 2023 15:57:26 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drugs-program-monthly-and-quarterly-activities-report Monthly and quarterly metrics of the FDA Generic Drugs Program. Fri, 01 Sep 2023 13:58:08 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drugs-program-monthly-and-quarterly-activities-report 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, 01 Sep 2023 12:20:40 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists 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. Fri, 01 Sep 2023 12:19:43 EDT FDA http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals 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, 01 Sep 2023 12:15:18 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers. Fri, 01 Sep 2023 10:17:14 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education 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. Fri, 01 Sep 2023 10:07:25 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner. FDA has begun an inventory of Fri, 01 Sep 2023 09:00:03 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments http://www.fda.gov/regulatory-information/search-fda-guidance-documents/post-warning-letter-meetings-under-gdufa Post-Warning Letter Meetings Under GDUFA Fri, 01 Sep 2023 08:45:02 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/post-warning-letter-meetings-under-gdufa http://www.fda.gov/regulatory-information/search-fda-guidance-documents/nontuberculous-mycobacterial-pulmonary-disease-caused-mycobacterium-avium-complex-developing-drugs Clinical/Antimicrobial Fri, 01 Sep 2023 08:45:02 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/nontuberculous-mycobacterial-pulmonary-disease-caused-mycobacterium-avium-complex-developing-drugs http://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Fri, 01 Sep 2023 08:26:53 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0 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, 01 Sep 2023 08:11:59 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. Thu, 31 Aug 2023 17:17:33 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp http://www.fda.gov/drugs/medication-health-fraud/tainted-arthritis-pain-products FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. Thu, 31 Aug 2023 13:34:22 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tainted-arthritis-pain-products http://www.fda.gov/drugs/medication-health-fraud/tapee-tea-contains-hidden-drug-ingredients The Food and Drug Administration is advising consumers not to purchase or use Tapee Tea, a product promoted and sold for pain relief on www.tapeeteausa.com, www.tapeetea.com, and possibly in some retail stores. Thu, 31 Aug 2023 13:32:14 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tapee-tea-contains-hidden-drug-ingredients http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP, Thu, 31 Aug 2023 13:01:40 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin http://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity FDA has proposed the development of a rating system that will help incentivize drug manufacturers to achieve Quality Mangement Maturity at their facilities. Thu, 31 Aug 2023 12:06:35 EDT FDA http://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity http://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the electronic, interoperable system will facilitate the exchange of information Thu, 31 Aug 2023 11:37:33 EDT FDA http://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Thu, 31 Aug 2023 09:36:54 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/news-events/fda-voices/update-fdas-overdose-prevention-framework-addressing-critical-areas-need An update on activities FDA is taking across the agency in each of the Overdose Prevention Framework priorities. Thu, 31 Aug 2023 09:04:25 EDT FDA http://www.fda.gov/news-events/fda-voices/update-fdas-overdose-prevention-framework-addressing-critical-areas-need