http://www.fda.gov/ en http://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion&#039;s untitled letters. <br /> FDA may have redacted or edited some of the letters to remove confidential information. Tue, 02 Jan 2024 10:48:44 EST FDA http://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Tue, 02 Jan 2024 10:44:53 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-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. Tue, 02 Jan 2024 10:42:58 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-lists http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Tue, 02 Jan 2024 10:39:21 EST FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions http://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) Tue, 02 Jan 2024 10:35:21 EST FDA http://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse http://www.fda.gov/drugs/news-events-human-drugs/endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023 The goal of this workshop is to stimulate discussion between the FDA, academicians, and industry representatives on endpoint and trial design to promote drug development in kidney transplantation. Tue, 02 Jan 2024 10:08:10 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023 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 Tue, 02 Jan 2024 10:00:00 EST FDA http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lone-star-botanicals-inc-659735-11062023 CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated<br /> Tue, 02 Jan 2024 09:20:05 EST FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lone-star-botanicals-inc-659735-11062023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/inopak-ltd-667411-12152023 CGMP/Finished Pharmaceuticals/Adulterated Tue, 02 Jan 2024 09:20:05 EST FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/inopak-ltd-667411-12152023 http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages Drug Shortages homepage Tue, 02 Jan 2024 08:24:26 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages 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. Fri, 29 Dec 2023 10:32:32 EST FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 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, 29 Dec 2023 09:52:47 EST FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring 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, 29 Dec 2023 09:41:45 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-information-applicants-chemistry-manufacturing-and-controls-ndas-andas-blas-and-ind Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications) Fri, 29 Dec 2023 09:35:42 EST FDA http://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-information-applicants-chemistry-manufacturing-and-controls-ndas-andas-blas-and-ind http://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs CDER is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic. Fri, 29 Dec 2023 09:29:46 EST FDA http://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs http://www.fda.gov/safety/reporting-serious-problems-fda/where-send-completed-form-fda-3500a-mandatory-reporting-form Where to Send Mandatory Reporting Forms (Pre-Marketing IND Safety and Post-Marketing Reports) Fri, 29 Dec 2023 08:45:04 EST FDA http://www.fda.gov/safety/reporting-serious-problems-fda/where-send-completed-form-fda-3500a-mandatory-reporting-form 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, 28 Dec 2023 12:22:27 EST 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/quality-considerations-topical-ophthalmic-drug-products Quality Considerations for Topical Ophthalmic Drug Products Thu, 28 Dec 2023 10:03:00 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-topical-ophthalmic-drug-products http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Thu, 28 Dec 2023 09:13:56 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco Thu, 28 Dec 2023 08:36:56 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization