What's New: Drugs RSS Feed http://www.fda.gov/ en FDA approves treatment for weight management in patients with Bardet-Biedl Syndrome aged 6 or older http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-weight-management-patients-bardet-biedl-syndrome-aged-6-or-older The U.S. Food and Drug Administration has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). Imcivree is the first drug approved specifically Fri, 24 Jun 2022 14:28:59 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-weight-management-patients-bardet-biedl-syndrome-aged-6-or-older 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 Fri, 24 Jun 2022 14:11:34 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists User Fee Lists http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016. Fri, 24 Jun 2022 14:07:33 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists 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 Fri, 24 Jun 2022 13:51:50 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations http://www.fda.gov/drugs/guidances-drugs/guidance-recap-podcast-assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Fri, 24 Jun 2022 13:00:10 EDT FDA http://www.fda.gov/drugs/guidances-drugs/guidance-recap-podcast-assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology What's New Related to Drugs 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. Fri, 24 Jun 2022 12:50:40 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Newly Added Guidance Documents 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. Fri, 24 Jun 2022 12:29:36 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics http://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-development-oligonucleotide-therapeutics Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry Fri, 24 Jun 2022 12:24:52 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-development-oligonucleotide-therapeutics Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP - 05/16/2022 http://www.fda.gov/drugs/news-events-human-drugs/pharmacokinetic-evaluation-pregnancy-virtual-public-workshop-05162022 Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP Fri, 24 Jun 2022 11:56:35 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/pharmacokinetic-evaluation-pregnancy-virtual-public-workshop-05162022 Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC): Key Themes and Future Directions from the January 2022 Public Workshop - 08/04/2022 http://www.fda.gov/drugs/news-events-human-drugs/endpoint-considerations-facilitate-drug-development-niemann-pick-type-c-npc-key-themes-and-future Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC):<br /> Key Themes and Future Directions from the January 2022 Public Workshop<br /> Fri, 24 Jun 2022 11:39:07 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/endpoint-considerations-facilitate-drug-development-niemann-pick-type-c-npc-key-themes-and-future Compounding Activities | COVID-19 http://www.fda.gov/drugs/coronavirus-covid-19-drugs/compounding-activities-covid-19 Providing guidance on compounded drugs Fri, 24 Jun 2022 11:02:16 EDT FDA http://www.fda.gov/drugs/coronavirus-covid-19-drugs/compounding-activities-covid-19 Considerations for Rescinding Breakthrough Therapy Designation http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-rescinding-breakthrough-therapy-designation Considerations for Rescinding Breakthrough Therapy Designation<br /> Guidance for Industry<br /> Fri, 24 Jun 2022 10:58:19 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-rescinding-breakthrough-therapy-designation Grimann S.A. de C.V. - 632272 - 06/03/2022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grimann-sa-de-cv-632272-06032022 Failure to Comply with Drug Registration and Listing Requirements Fri, 24 Jun 2022 10:41:53 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grimann-sa-de-cv-632272-06032022 Grimann S.A. de C.V. - 632272 - 05/23/2022 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grimann-sa-de-cv-632272-05232022 Failure to Comply with Drug Registration and Listing Requirements Fri, 24 Jun 2022 10:40:00 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grimann-sa-de-cv-632272-05232022 Office of New Drugs (OND) | Annual Reports http://www.fda.gov/drugs/office-new-drugs-ond-annual-reports This report offers readers insight into OND’s priorities through a message from the Director. Fri, 24 Jun 2022 09:41:09 EDT FDA http://www.fda.gov/drugs/office-new-drugs-ond-annual-reports Search for Regulatory References | Drugs http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/search-regulatory-references-drugs Find information on drug development, applications, submissions, manufacturing &amp; quality, safety, labeling and more Fri, 24 Jun 2022 09:38:07 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/search-regulatory-references-drugs Reports & Budgets | CDER http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/reports-budgets-cder Reports and budgets from CDER offices and divisions Fri, 24 Jun 2022 09:35:59 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/reports-budgets-cder Office of New Drugs (OND) | Annual Reports http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs-ond-annual-reports This report offers readers insight into OND’s priorities through a message from the Director. Fri, 24 Jun 2022 09:31:51 EDT FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs-ond-annual-reports Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry http://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-alternate-electronic-format-guidance-industry Electronic Submissions Fri, 24 Jun 2022 08:45:02 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-alternate-electronic-format-guidance-industry Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination http://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-penicillin-beta-lactam-drugs-cgmp-framework-preventing-cross-contamination-0 Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination Fri, 24 Jun 2022 08:19:22 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-penicillin-beta-lactam-drugs-cgmp-framework-preventing-cross-contamination-0