What's New: Drugs RSS Feed http://www.fda.gov/ en What's New Related to Drugs 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 Drug Trials Snapshots 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 Novel Drug Approvals for 2022 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 Drugs 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 Consumer Updates 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 Zhao Qing Longda Biotechnology Co. Ltd. - 664934 - 09/18/2023 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 Gulf States International, Inc. - 666918 - 09/12/2023 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 Novel Drug Approvals for 2023 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 Drug Shortages 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 Compounding: Inspections, Recalls, and other Actions 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 Registered Outsourcing Facilities 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 Antimicrobial Resistance Information from FDA 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 Dermatologic and Ophthalmic Drugs Advisory Committee Roster 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 Tainted Sleep Aid Products 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 Defining 'Candy-Like' Nonprescription Drug Products - 10/30/2023 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 Generic Drug Facilities, Sites and Organization Lists 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 Abbreviated New Drug Application (ANDA) Forms and Submission Requirements 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 GDUFA Paid Facilities List 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 VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus 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 Increasing the Efficiency of Biosimilar Development Programs--Reevaluating the Need for Comparative Clinical Efficacy Studies - 09/12/2023 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