http://www.fda.gov/ en 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 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. Fri, 29 Sep 2023 16:59:54 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding http://www.fda.gov/drugs/news-events-human-drugs/notable-approvals-drugs News about human drug-related approvals Fri, 29 Sep 2023 16:53:05 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/notable-approvals-drugs http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tender-corporation-dba-adventure-ready-brand-599789-09282023 CGMP/Finished Pharmaceuticals/Adulterated Fri, 29 Sep 2023 16:07:35 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tender-corporation-dba-adventure-ready-brand-599789-09282023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tender-corporation-599789-07232020 CGMP/Finished Pharmaceuticals/Adulterated Fri, 29 Sep 2023 16:06:52 EDT Division of Pharmaceutical Quality Operations I http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tender-corporation-599789-07232020 http://www.fda.gov/news-events/press-announcements/fda-roundup-september-29-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 29 Sep 2023 16:01:42 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-29-2023 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, 29 Sep 2023 16:00:56 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists 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 Fri, 29 Sep 2023 16:00:03 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/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, 29 Sep 2023 14:34:43 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-drugs-advisory-committee-roster This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee. Fri, 29 Sep 2023 14:18:47 EDT FDA http://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-drugs-advisory-committee-roster http://www.fda.gov/drugs/medication-health-fraud/reumo-flex-contains-hidden-drug-ingredient The Food and Drug Administration is advising consumers not to purchase or use Reumo Flex, a product promoted and sold for joint pain and arthritis on various websites, including https://botanical-be.com, and possibly in some retail stores. Fri, 29 Sep 2023 13:22:21 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/reumo-flex-contains-hidden-drug-ingredient http://www.fda.gov/drugs/medication-health-fraud/kuka-flex-forte-contains-hidden-drug-ingredient The Food and Drug Administration is advising consumers not to purchase or use Kuka Flex Forte, a product promoted and sold for joint pain and arthritis on various websites, including https://botanical-be.com, and possibly in some retail stores. Fri, 29 Sep 2023 13:22:18 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/kuka-flex-forte-contains-hidden-drug-ingredient 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. Fri, 29 Sep 2023 13:10:25 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. Fri, 29 Sep 2023 13:07:44 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tapee-tea-contains-hidden-drug-ingredients http://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection-december Guidance for industry on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022) Fri, 29 Sep 2023 13:04:35 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection-december