http://www.fda.gov/ en http://www.fda.gov/advisory-committees/anesthetic-and-analgesic-drug-products-advisory-committee/anesthetic-and-analgesic-drug-products-advisory-committee-roster This page contains the AADPAC roster, which lists the current members and the current number of vacancies for the committee. Fri, 31 Mar 2023 17:28:58 EDT FDA http://www.fda.gov/advisory-committees/anesthetic-and-analgesic-drug-products-advisory-committee/anesthetic-and-analgesic-drug-products-advisory-committee-roster http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dabrafenib-trametinib-pediatric-patients-low-grade-glioma-braf-v600e-mutation On March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formula Fri, 31 Mar 2023 16:12:06 EDT FDA http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dabrafenib-trametinib-pediatric-patients-low-grade-glioma-braf-v600e-mutation http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product. : In the population most at risk, immunocompromised population, there is a reasonable proba Fri, 31 Mar 2023 15:52:56 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring FDA/CDER employment opportunities utilizing the FDA 21st Century Cures Act Hiring Authority Fri, 31 Mar 2023 15:43:31 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-questions-and-answers Get additional information about disposal of unused or expired drugs Fri, 31 Mar 2023 15:04:16 EDT FDA http://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-questions-and-answers http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers. Fri, 31 Mar 2023 13:03:56 EDT FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Fri, 31 Mar 2023 09:56:01 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2023-celebrating-10-years-gdf-04122023 The GDF is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. Fri, 31 Mar 2023 09:38:27 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2023-celebrating-10-years-gdf-04122023 http://www.fda.gov/regulatory-information/search-fda-guidance-documents/identification-medicinal-products-implementation-and-use Identification of Medicinal Products — Implementation and Use Fri, 31 Mar 2023 08:57:20 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/identification-medicinal-products-implementation-and-use http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. Fri, 31 Mar 2023 08:44:08 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents 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. Fri, 31 Mar 2023 08:40:55 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/procter-gamble-manufactura-s-de-rl-de-cv-650837-03272023 Failure to Register and List Fri, 31 Mar 2023 07:16:34 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/procter-gamble-manufactura-s-de-rl-de-cv-650837-03272023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/procter-gamble-manufactura-s-de-rl-de-cv-650837-03142023 Failure to Register and List Fri, 31 Mar 2023 07:15:53 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/procter-gamble-manufactura-s-de-rl-de-cv-650837-03142023 http://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse Thu, 30 Mar 2023 19:07:07 EDT FDA http://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose http://www.fda.gov/news-events/fda-newsroom/fda-voices Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco. Thu, 30 Mar 2023 15:47:32 EDT FDA http://www.fda.gov/news-events/fda-newsroom/fda-voices http://www.fda.gov/drugs/cder-foia-electronic-reading-room/frequently-requested-or-proactively-posted-compliance-records Frequently requested inspection records of foreign pharmaceutical manufacturing facilities Thu, 30 Mar 2023 14:55:09 EDT FDA http://www.fda.gov/drugs/cder-foia-electronic-reading-room/frequently-requested-or-proactively-posted-compliance-records http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal-product-development The purpose of this guidance is to provide a framework for considering whether and what type of 59 long-term neurologic, sensory and developmental evaluations could be useful to support a 60 determination of safety of a drug, biological product, or device. Thu, 30 Mar 2023 14:23:44 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal-product-development http://www.fda.gov/about-fda/histories-fda-regulated-products/history-drug-regulation Resources on the history of FDA's regulation of drugs Thu, 30 Mar 2023 14:23:38 EDT FDA http://www.fda.gov/about-fda/histories-fda-regulated-products/history-drug-regulation http://www.fda.gov/advisory-committees/psychopharmacologic-drugs-advisory-committee/2020-meeting-materials-psychopharmacologic-drugs-advisory-committee 2020 Meeting Materials, Psychopharmacologic Drugs Advisory Committee Thu, 30 Mar 2023 13:02:41 EDT FDA http://www.fda.gov/advisory-committees/psychopharmacologic-drugs-advisory-committee/2020-meeting-materials-psychopharmacologic-drugs-advisory-committee http://www.fda.gov/advisory-committees/psychopharmacologic-drugs-advisory-committee/2021-meeting-materials-psychopharmacologic-drugs-advisory-committee 2021 Meeting Materials, Psychopharmacologic Drugs Advisory Committee Thu, 30 Mar 2023 13:02:20 EDT FDA http://www.fda.gov/advisory-committees/psychopharmacologic-drugs-advisory-committee/2021-meeting-materials-psychopharmacologic-drugs-advisory-committee