http://www.fda.gov/ en 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. Thu, 01 Jun 2023 16:31:30 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/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-prea-2012-present The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA. Thu, 01 Jun 2023 16:08:06 EDT FDA http://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-prea-2012-present http://www.fda.gov/consumers/consumer-updates/dont-use-products-marketed-treat-molluscum-common-skin-condition A common skin infection that some people try to self-diagnose and treat is molluscum contagiosum. But by doing so, you run the risk of delaying the diagnosis and treatment of a potentially serious condition. The FDA has not approved any products for the treatment of molluscum. Thu, 01 Jun 2023 15:29:36 EDT FDA http://www.fda.gov/consumers/consumer-updates/dont-use-products-marketed-treat-molluscum-common-skin-condition http://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2023-06052023 Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. Thu, 01 Jun 2023 13:08:52 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2023-06052023 http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what&#039;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 Jun 2023 11:05:13 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA&#039;s current thinking on a particular subject. New guidance documents are listed here for three months. Thu, 01 Jun 2023 10:59:08 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/regulatory-information/search-fda-guidance-documents/migraine-developing-drugs-preventive-treatment Migraine: Developing Drugs for Preventive Treatment Thu, 01 Jun 2023 10:52:10 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/migraine-developing-drugs-preventive-treatment http://www.fda.gov/consumers/consumer-updates/drugs Consumer articles about over-the-counter and prescription drugs. Thu, 01 Jun 2023 10:47:57 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. Thu, 01 Jun 2023 10:45:20 EDT FDA http://www.fda.gov/consumers/consumer-updates 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 Jun 2023 10:27:44 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists 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 Jun 2023 09:30:04 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/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 approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups. Thu, 01 Jun 2023 09:21:33 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-pyrukynd PYRUKYND is a drug used to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Thu, 01 Jun 2023 09:10:35 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-pyrukynd http://www.fda.gov/drugs/news-events-human-drugs/drug-shortages-cdr-emily-thakur In this podcast series, we answer some of the most frequently asked questions we’ve received from the public. Thu, 01 Jun 2023 08:52:59 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/drug-shortages-cdr-emily-thakur http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-05232023 CGMP/Finished Pharmaceuticals/Adulterated Thu, 01 Jun 2023 07:30:51 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-05232023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 CGMP/Finished Pharmaceuticals/Adulterated<br /> Thu, 01 Jun 2023 07:30:50 EDT Center for Drug Evaluation and Research http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cali-botanicals-llc-575320-06112019 Unapproved New Drug/Misbranded Thu, 01 Jun 2023 07:18:37 EDT Center for Drug Evaluation and Research http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cali-botanicals-llc-575320-06112019 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/icerx-1111111-10092018 IceRx, Finished Pharmaceuticals/Unapproved New Drug/Misbranded Thu, 01 Jun 2023 07:12:04 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/icerx-1111111-10092018 http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-and-nihnci-center-cancer-research-advancing-drug-development-myelodysplastic-syndromes-05162023 FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes. Virtual 2-day free public workshop. Thu, 01 Jun 2023 06:55:55 EDT FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-and-nihnci-center-cancer-research-advancing-drug-development-myelodysplastic-syndromes-05162023 http://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations. Thu, 01 Jun 2023 00:10:14 EDT FDA http://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot