http://www.fda.gov/ en http://www.fda.gov/safety/medical-product-safety-information/alcohol-based-hand-sanitizer-drug-safety-communication-getting-eyes-can-cause-serious-injury The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure has occurred most often in children. Tue, 02 Nov 2021 11:20:59 EDT FDA http://www.fda.gov/safety/medical-product-safety-information/alcohol-based-hand-sanitizer-drug-safety-communication-getting-eyes-can-cause-serious-injury 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. Tue, 02 Nov 2021 10:54:02 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-getting-alcohol-based-hand-sanitizer-eyes-can-cause-serious-injury FDA is warning that getting alcohol-based hand sanitizer in the eyes can cause serious injury. If this occurs, immediately rinse with running water for 15 to 20 minutes<br /> Tue, 02 Nov 2021 10:52:21 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-getting-alcohol-based-hand-sanitizer-eyes-can-cause-serious-injury http://www.fda.gov/industry/generic-drug-user-fee-amendments/activities-report-generic-drugs-program-gdufa-ii-quarterly-performance In section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization for Fiscal Years 2018-2022 (GDUFA II Commitment Letter), FDA committed to publishing quarterly metrics.<br /> Tue, 02 Nov 2021 10:41:14 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/activities-report-generic-drugs-program-gdufa-ii-quarterly-performance http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public Tue, 02 Nov 2021 10:01:45 EDT FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/proper-nutrition-inc-612435-04202021 New Drug/Misbranded<br /> Tue, 02 Nov 2021 09:20:05 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/proper-nutrition-inc-612435-04202021 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dongbang-cosmetics-co-ltd-610364-10222021 CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated Tue, 02 Nov 2021 09:20:05 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dongbang-cosmetics-co-ltd-610364-10222021 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dominant-nutrition-llc-formerly-8-weeks-out-labs-613688-10212021 Dietary Supplement/Adulterated Tue, 02 Nov 2021 09:20:04 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dominant-nutrition-llc-formerly-8-weeks-out-labs-613688-10212021 http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/related-botanical-links Related Botanical Links Tue, 02 Nov 2021 09:09:32 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/related-botanical-links http://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-information-november-4-2021-meeting-psychopharmacologic-drugs-advisory-committee-pdac November 4, 2021: Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) Meeting Announcement Tue, 02 Nov 2021 08:40:03 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-information-november-4-2021-meeting-psychopharmacologic-drugs-advisory-committee-pdac http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-paid-facilities-list This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list: Mon, 01 Nov 2021 15:39:23 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-paid-facilities-list http://www.fda.gov/advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee/pharmaceutical-science-and-clinical-pharmacology-advisory-committee-roster This page contains the Pharmaceutical Science and Clinical Pharmacology Advisory Committee roster, which lists the current members and the current number of vacancies for the committee. Mon, 01 Nov 2021 14:10:33 EDT FDA http://www.fda.gov/advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee/pharmaceutical-science-and-clinical-pharmacology-advisory-committee-roster http://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-exports Human drug export information including certificates of pharmaceutical product (CPP) and CGMP declarations Mon, 01 Nov 2021 13:20:17 EDT FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-exports http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Mon, 01 Nov 2021 13:13:46 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Mon, 01 Nov 2021 12:51:25 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol Mon, 01 Nov 2021 11:40:46 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use 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, 01 Nov 2021 11:21:42 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists 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. Mon, 01 Nov 2021 11:19:47 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/drugs/news-events-human-drugs/integrated-assessment-marketing-applications-virtual-workshop-10302020-10302020 Integrated Assessment of Marketing Applications Virtual Workshop Mon, 01 Nov 2021 10:34:02 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/integrated-assessment-marketing-applications-virtual-workshop-10302020-10302020 http://www.fda.gov/drugs/drug-safety-and-availability/2021-drug-safety-communications 2021 Drug Safety Communications Mon, 01 Nov 2021 06:50:23 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/2021-drug-safety-communications