http://www.fda.gov/ en http://www.fda.gov/drugs/development-resources/antifungal-susceptibility-test-interpretive-criteria Antifungal Susceptibility Test Interpretive Criteria Thu, 01 Dec 2022 14:03:33 EST FDA http://www.fda.gov/drugs/development-resources/antifungal-susceptibility-test-interpretive-criteria http://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans, using the Accelerated Approval pathway Thu, 01 Dec 2022 08:47:12 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information Aduhelm is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. Thu, 01 Dec 2022 07:56:31 EST FDA http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased FDA alerts patients and health care professionals that a clinical trial evaluating Pepaxto (melphalan flufenamide) showed an increased risk of death. Thu, 01 Dec 2022 07:48:40 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-adults-rare-form-bone-marrow-disorder FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate or high-risk primary or secondary myelofibrosis and who have platelet (blood clotting cells) levels below 50,000/µL. Thu, 01 Dec 2022 07:47:04 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-adults-rare-form-bone-marrow-disorder http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-excluding-vaccines Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint Thu, 01 Dec 2022 07:24:16 EST FDA http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-excluding-vaccines http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-non-malignant-hematological-neurological-and-other-disorder-indications Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint Thu, 01 Dec 2022 07:23:01 EST FDA http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-non-malignant-hematological-neurological-and-other-disorder-indications http://www.fda.gov/drugs/accelerated-approval-program/withdrawn-infectious-disease-accelerated-approvals Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint Thu, 01 Dec 2022 07:22:03 EST FDA http://www.fda.gov/drugs/accelerated-approval-program/withdrawn-infectious-disease-accelerated-approvals http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-vaccines Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint Thu, 01 Dec 2022 07:21:30 EST FDA http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-vaccines http://www.fda.gov/drugs/accelerated-approval-program/ongoing-infectious-disease-accelerated-approvals-excluding-vaccines Ongoing | Infectious Disease Accelerated Approvals (excluding vaccines) Thu, 01 Dec 2022 07:19:35 EST FDA http://www.fda.gov/drugs/accelerated-approval-program/ongoing-infectious-disease-accelerated-approvals-excluding-vaccines http://www.fda.gov/drugs/accelerated-approval-program/ongoing-non-malignant-hematology-neurological-disorders-and-other-indications-accelerated-approvals Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint Thu, 01 Dec 2022 07:18:41 EST FDA http://www.fda.gov/drugs/accelerated-approval-program/ongoing-non-malignant-hematology-neurological-disorders-and-other-indications-accelerated-approvals http://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint Thu, 01 Dec 2022 07:17:30 EST FDA http://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program 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. Wed, 30 Nov 2022 18:46:14 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs 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. Wed, 30 Nov 2022 18:31:34 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR. Wed, 30 Nov 2022 17:29:40 EST FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda http://www.fda.gov/regulatory-information/search-fda-guidance-documents/in-vitro-permeation-test-studies-topical-drug-products-submitted-andas In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Wed, 30 Nov 2022 15:20:00 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/in-vitro-permeation-test-studies-topical-drug-products-submitted-andas http://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-bebtelovimab-not-currently-authorized-any-us-region FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region due to the rise in SARS-CoV-2 variants that it is not expected to neutralize Wed, 30 Nov 2022 14:40:12 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-bebtelovimab-not-currently-authorized-any-us-region http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab FDA is providing updates on the effectiveness of bebtelovimab as a COVID-19 therapeutic option against certain subvariants of SARS-CoV-2 Wed, 30 Nov 2022 14:18:44 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages Drug Shortages homepage Wed, 30 Nov 2022 13:38:41 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages 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. Wed, 30 Nov 2022 12:55:48 EST FDA http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals