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. Tue, 26 Sep 2023 11:24:08 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent. Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approv Tue, 26 Sep 2023 11:19:49 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 Innovative drugs often mean new treatment options for patients and advances in health care for the American public. Tue, 26 Sep 2023 11:17:30 EDT FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 http://www.fda.gov/consumers/consumer-updates/drugs Consumer articles about over-the-counter and prescription drugs. Tue, 26 Sep 2023 09:54:22 EDT FDA http://www.fda.gov/consumers/consumer-updates/drugs http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Tue, 26 Sep 2023 09:49:57 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhao-qing-longda-biotechnology-co-ltd-664934-09182023 Refusal to Provide Access to and Copying of Records Tue, 26 Sep 2023 09:20:03 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhao-qing-longda-biotechnology-co-ltd-664934-09182023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gulf-states-international-inc-666918-09122023 Refusal to Provide Access to and Copying of Records Tue, 26 Sep 2023 09:20:02 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gulf-states-international-inc-666918-09122023 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. Tue, 26 Sep 2023 09:09:25 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/drug-safety-and-availability/drug-shortages Drug Shortages homepage Mon, 25 Sep 2023 15:47:01 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Mon, 25 Sep 2023 14:12:17 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individua Mon, 25 Sep 2023 14:05:23 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities 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. Mon, 25 Sep 2023 12:01:13 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda http://www.fda.gov/advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee/dermatologic-and-ophthalmic-drugs-advisory-committee-roster This page contains the DODAC roster, which lists the current members and the current number of vacancies for the committee. Mon, 25 Sep 2023 11:45:40 EDT FDA http://www.fda.gov/advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee/dermatologic-and-ophthalmic-drugs-advisory-committee-roster http://www.fda.gov/drugs/medication-health-fraud/tainted-sleep-aid-products Medication Health Fraud products that are tainted Sleep Aid Products Mon, 25 Sep 2023 11:04:32 EDT FDA http://www.fda.gov/drugs/medication-health-fraud/tainted-sleep-aid-products http://www.fda.gov/drugs/news-events-human-drugs/defining-candy-nonprescription-drug-products-10302023 In anticipation of potential OTC monograph drug dosage form innovation, FDA is seeking ways to further define features of nonprescription drug products that could be considered “candy-like.” Mon, 25 Sep 2023 10:44:22 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/defining-candy-nonprescription-drug-products-10302023 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, 25 Sep 2023 10:04:48 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/abbreviated-new-drug-application-anda-forms-and-submission-requirements This page is a resource for ANDA Forms and Submission Requirements Mon, 25 Sep 2023 09:59:26 EDT FDA http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/abbreviated-new-drug-application-anda-forms-and-submission-requirements 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, 25 Sep 2023 09:57:56 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-paid-facilities-list http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vistapharm-llc-issues-voluntary-nationwide-recall-sucralfate-oral-suspension-1g10ml-due-microbial September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. Fri, 22 Sep 2023 20:50:46 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vistapharm-llc-issues-voluntary-nationwide-recall-sucralfate-oral-suspension-1g10ml-due-microbial http://www.fda.gov/drugs/news-events-human-drugs/increasing-efficiency-biosimilar-development-programs-reevaluating-need-comparative-clinical Increasing the Efficiency of Biosimilar Development Programs--Reevaluating the Need for Comparative Clinical Efficacy Studies Fri, 22 Sep 2023 16:59:04 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/increasing-efficiency-biosimilar-development-programs-reevaluating-need-comparative-clinical