http://www.fda.gov/ en http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. Thu, 01 Feb 2024 16:01:47 EST FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp 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. Thu, 01 Feb 2024 15:09:46 EST 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-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection Thu, 01 Feb 2024 11:43:30 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Thu, 01 Feb 2024 11:29:23 EST FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions http://www.fda.gov/advisory-committees/peripheral-and-central-nervous-system-drugs-advisory-committee/peripheral-and-central-nervous-system-drugs-advisory-committee-roster This page contains the Peripheral and Central Nervous System Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee Thu, 01 Feb 2024 11:29:10 EST FDA http://www.fda.gov/advisory-committees/peripheral-and-central-nervous-system-drugs-advisory-committee/peripheral-and-central-nervous-system-drugs-advisory-committee-roster http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Thu, 01 Feb 2024 11:02:06 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/biosimilars/multimedia-education-materials-biosimilars FDA offers a variety of materials in multiple formats to help promote understanding of biosimilars and interchangeable products. Thu, 01 Feb 2024 10:51:10 EST FDA http://www.fda.gov/drugs/biosimilars/multimedia-education-materials-biosimilars http://www.fda.gov/consumers/consumer-updates/drugs Consumer articles about over-the-counter and prescription drugs. Thu, 01 Feb 2024 10:00:06 EST FDA http://www.fda.gov/consumers/consumer-updates/drugs http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-metrics FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs. Thu, 01 Feb 2024 09:52:38 EST FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-metrics 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. Thu, 01 Feb 2024 09:46:29 EST 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/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 Thu, 01 Feb 2024 09:44:34 EST FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Thu, 01 Feb 2024 09:44:13 EST FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-roster This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee. Thu, 01 Feb 2024 09:05:39 EST FDA http://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-roster http://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan The FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program. Thu, 01 Feb 2024 08:15:10 EST FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan http://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan-improving-efficiency-generic-drug-development-review-and-approval By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval. Thu, 01 Feb 2024 08:12:56 EST FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan-improving-efficiency-generic-drug-development-review-and-approval http://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation. Wed, 31 Jan 2024 17:21:19 EST FDA http://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs http://www.fda.gov/drugs/buying-using-medicine-safely/what-you-should-know-about-eye-drops Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs. Wed, 31 Jan 2024 14:02:30 EST FDA http://www.fda.gov/drugs/buying-using-medicine-safely/what-you-should-know-about-eye-drops http://www.fda.gov/drugs/biomarker-qualification-program/biomarker-qualification-submissions The FDA CDER Biomarker Qualification Program invites submitters who have a biomarker qualification project accepted into the Program to voluntarily provide general information about their project and contact information to be posted on the FDA’s public web site. The table below lists submissions tha Wed, 31 Jan 2024 13:51:45 EST FDA http://www.fda.gov/drugs/biomarker-qualification-program/biomarker-qualification-submissions http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements FDA Drug Alerts and Statements Wed, 31 Jan 2024 12:39:22 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye infection. Wed, 31 Jan 2024 12:36:01 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops