Drugs - FDA

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United ... Skiptomaincontent SkiptoFDASearch Skiptointhissectionmenu Skiptofooterlinks Inthissection: Drugs Drugs RegulatoryScienceResearchandEducation Development&ApprovalProcess|Drugs DrugSafetyandAvailability EmergencyPreparedness|Drugs Guidance,Compliance,&RegulatoryInformation News&EventsforHumanDrugs ResourcesforYou|Drugs ScienceandResearch|Drugs Home TopicParagraphs FDAHealthPlaybookPSAstohighlightimportanceofsunscreenprotection Oct13-SpotswillfeatureNFLHallofFamerDarrellGreenandotherathletes AnnualdrugregistrationrenewalperiodnowopenthroughDecember31 Oct11-Actionrequiredtokeepdrugregistrationstatuscurrentin2023 CDERannouncespre-consortiumwiththeCriticalPathInstitute Oct6-AimstoexplorepossibilityofanAlpha-1AntitrypsinDeficiencyConsortium FDAtoaddressdrugdevelopmentofproductsthatcontainnanomaterials Eventwillhighlighthowanewlyfinalizedguidancecanbeimplemented FDAtodiscussbioavailabilityconsiderations(BA)fordrugsubmissions EventwillclarifyBAguidance,discusscasestudiesandofferQ&Apanel NovembereventwilldiscussthefutureofQualityManagementMaturity(QMM)programandnextstagesofKnowledge-AidedAssessmentandStructuredApplication(KASA). FDAtohostadvisorymeetingonQMMprogramandKASA EventtodiscussfutureofQMMprogramandnextstagesofKASA DrugInformation,Safety,andAvailability MedicationGuides,DrugSafetyCommunications,Shortages,Recalls DrugApprovalsandDatabases Drugs@FDA,OrangeBook,NationalDrugCode,Recentdrugapprovals DrugDevelopmentandReviewProcess Drugapplications,submissions,manufacturing,andsmallbusinesshelp Guidance,Compliance,andRegulatoryInformation Guidances,warningletters,drugcompounding,internationalinformation,registrationandlisting RegulatoryScienceandResearch CDERresearchprograms,initiatives,andresources EmergencyPreparedness Prepareandrespondtonaturaldisasters,nuclearandchemicalattacks Updates,News,Events,andTraining Recentapprovals,meetings,workshops,blogs,podcasts,stayconnected AbouttheCenterforDrugEvaluationandResearch(CDER) Ourrole,mission,organization,history,leadership,jobopenings DisposalofUnusedMedicines:WhatYouShouldKnow Theshortvideoshowsyouhowtoproperlygetridofunusedorexpiredmedication Grandmotherismeasuringherbloodpressureinthelivingroom. HighBloodPressure–UnderstandingtheSilentKiller Itcanleadtomanyseriousproblemsthat’swhyit’simportanttoknowyourriskfactors BeSafeRx:YourSourceforOnlinePharmacyInformation Exploreresourcesandtoolssoyoucansafelybuyprescriptionmedicinesonline Coronavirus(COVID-19) Getthelatestnewsandinformationregardingtheglobalpandemic Opioids Reducingtheimpactofopioidmisuseandabuse Generics Ensuringaccesstosafe,affordable,andeffectivegenericdrugs WarningLetters WarningandNoticeofViolationLetterstoPharmaceuticalCompanies Guidances FDA'scurrentthinkingondrugdevelopmentandreviewactivities DrugShortages Searchthedatabase,learnaboutrootcausesandpotentialsolutions ResourcesforYou Informationforconsumers,healthprofessionals,andindustry DisposalofUnusedMedicines Learnhowtoproperlygetridofunusedorexpiredmedication CENTERFORDRUGEVALUATIONANDRESEARCH OfficeofCommunications 10001NewHampshireAve HillandaleBuilding,4thFl SilverSpring,MD20993 [email protected] TollFree (855)543-3784 (301)796-3400 HoursAvailable CDERDivisionofDrugInformation ParagraphHeader(Column2) FORUPDATESONTWITTERFOLLOW @FDA_Drug_Info Yoursourceforthelatestdruginformation. Knowthemomentithappens. BacktoTop