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. Mon, 02 Oct 2023 15:23:18 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/biomic-sciences-issues-voluntary-nationwide-recall-ion-sinus-support-ion-biome-sinus-and-restore Charlottesville, VA - Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products to the consumer level. FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., Mon, 02 Oct 2023 14:20:34 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/biomic-sciences-issues-voluntary-nationwide-recall-ion-sinus-support-ion-biome-sinus-and-restore http://www.fda.gov/drugs/news-events-human-drugs/cder-collaborates-global-regulators-pharmaceutical-quality-assessments-and-inspections Regulators collaboration enable industry to reliably supply critical medicines for patients Mon, 02 Oct 2023 13:55:20 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/cder-collaborates-global-regulators-pharmaceutical-quality-assessments-and-inspections http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Mon, 02 Oct 2023 13:35:37 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions 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. Mon, 02 Oct 2023 12:49:41 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Mon, 02 Oct 2023 12:45:27 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/industry/structured-product-labeling-resources/marketing-category This is the list of marketing categories which may be used in Structured Product Labeling (SPL) documents which are sent to FDA. Mon, 02 Oct 2023 12:17:17 EDT FDA http://www.fda.gov/industry/structured-product-labeling-resources/marketing-category http://www.fda.gov/drugs/information-consumers-and-patients-drugs/fda-warns-about-heavy-metal-poisoning-associated-certain-unapproved-ayurvedic-drug-products Use of unapproved ayurvedic drug products containing harmful levels of heavy metals may cause heavy metal poisoning Mon, 02 Oct 2023 11:50:24 EDT FDA http://www.fda.gov/drugs/information-consumers-and-patients-drugs/fda-warns-about-heavy-metal-poisoning-associated-certain-unapproved-ayurvedic-drug-products http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers. Mon, 02 Oct 2023 11:48:04 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education 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 Mon, 02 Oct 2023 11:21:08 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/human-prescription-drug-and-biological-products-labeling-dosing-based-weight-or-body-surface-area Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” Mon, 02 Oct 2023 10:42:53 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-prescription-drug-and-biological-products-labeling-dosing-based-weight-or-body-surface-area http://www.fda.gov/drugs/drug-approvals-and-databases/quarterly-inactive-ingredient-database-iid-change-log Quarterly IID Change Log displays changes made since the previous quarterly IID publication. Mon, 02 Oct 2023 09:58:55 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/quarterly-inactive-ingredient-database-iid-change-log http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 Each year, CDER approves a wide range of new drugs and biological products. Mon, 02 Oct 2023 09:39:50 EDT FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 http://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/april-june-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) Mon, 02 Oct 2023 08:45:04 EDT FDA http://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/april-june-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event http://www.fda.gov/advisory-committees/cardiovascular-and-renal-drugs-advisory-committee/cardiovascular-and-renal-drugs-advisory-committee-roster Advisory Committees (Drugs) Fri, 29 Sep 2023 17:48:14 EDT FDA http://www.fda.gov/advisory-committees/cardiovascular-and-renal-drugs-advisory-committee/cardiovascular-and-renal-drugs-advisory-committee-roster http://www.fda.gov/drugs/biosimilars/biosimilar-product-information This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs. Fri, 29 Sep 2023 17:31:18 EDT FDA http://www.fda.gov/drugs/biosimilars/biosimilar-product-information 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 Fri, 29 Sep 2023 17:08:34 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/safety-risks-associated-certain-bulk-drug-substances-nominated-use-compounding http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shot-joy-llc-665936-09252023 Unapproved New Drugs/Misbranded Fri, 29 Sep 2023 17:00:05 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shot-joy-llc-665936-09252023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/southern-tier-home-infusion-inc-dba-pharmacy-innovations-667414-09202023 Compounding Pharmacy/Adulterated Drug Products Fri, 29 Sep 2023 17:00:04 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/southern-tier-home-infusion-inc-dba-pharmacy-innovations-667414-09202023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/luis-javier-pena-hernandez-md-fccp-668217-09202023 Clinical Investigator Fri, 29 Sep 2023 17:00:03 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/luis-javier-pena-hernandez-md-fccp-668217-09202023