MAPP 5015.14 与未同步审评的 ANDA 或 PAS 相关的已征集 DMF 修订优先排序

5017.2 Rev. 2Office of Pharmaceutical QualityAssessing Impurity Acceptance Criteria as Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical RelevanceRegulatory Review and Scientific Policies5/14/20265200.11Office of Generic DrugsPrescription to Nonprescription Switches and Abbreviated New Drug ApplicationsGeneric Drug Review12/8/20255221.3 Rev. 1Office of Generic DrugsUsing Four-Part Harmony in OGD-Related Assessment CommunicationsGeneric Drug Review11/12/20254151.8 Rev. 2Office of Executive ProgramsEqual Voice: Collaboration and Regulatory and Policy Decision-Making in CDERLeadership and Mission8/12/20255015.13 Rev. 1Office of Pharmaceutical QualityQuality Assessment for Products in Expedited ProgramsRegulatory Review and Scientific Policies7/31/20256025.9Office of New DrugsGood Review Practices: Standard Safety Tables and FiguresNew Drug Review6/13/20256025.8Office of New DrugsGood Review Practices: OND Custom Medical QueriesNew Drug Review6/13/20256020.14 Rev. 2Office of New DrugsInterdisciplinary Review Team for Cardiac Safety StudiesNew Drug Review10/21/20246030.9Office of New DrugsReview Practice:  Good Review Management Principles and Practices for Effective IND Development and ReviewNew Drug Review4/29/20135015.14Office of Pharmaceutical QualityPrioritization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under AssessmentRegulatory Review and Scientific Policies5/7/20245018.3Office of Pharmaceutical QualityImplementation of Established Conditions as Described in ICH Q12Regulatory Review and Scientific Policies10/16/20247610.1Office of Strategic ProgramsCDER Records ManagementInformation Technology3/22/20246702.3Office of Surveillance and EpidemiologyReview of Proposed Methodological Approaches to Assess a Risk Evaluation and Mitigation Strategy (REMS) Drug Safety3/25/20246702.1Office of Surveillance and EpidemiologyReview of Risk Evaluation and Mitigation Strategy (REMS) Assessment ReportsDrug Safety3/25/20245017.8 Rev. 1Office of Pharmaceutical QualityResponsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding TubeRegulatory Review and Scientific Policies1/8/20265016.8 Rev. 1Office of Pharmaceutical QualityUsing Four-Part Harmony in Quality-Related Assessment CommunicationsRegulatory Review and Scientific Policies8/25/20234301.1 Rev. 4Office of Medical PolicyCenter for Drug Evaluation and Research Medical Policy and Program Review CouncilLeadership and Mission7/16/20265021.5 Rev. 1Office of Pharmaceutical QualityAssessment of Facility-Based Deficiency Major-to-Minor Reclassification RequestsRegulatory Review and Scientific Policies12/21/20236021.1 Rev.1Office of New DrugsNDAs/BLAs: Financial DisclosureNew Drug Review10/9/20244100.2Office of Translational Sciences

CDER Staff Participation in Public Private Partnerships and Consortia

• Request for CDER Participation in a Public Private Partnership or Consortium Activity Form
• CDER Public-Private Partnership (PPP) Liaison Initiation Form
• CDER Public Private Partnership (PPP) Liaison Annual Update Form

Regulatory Review and Scientific Policies4/21/20235100.3Office of Clinical PharmacologyOCP Prioritization, Triage, and Review Process for INDs and Pre-INDsRegulatory Review and Scientific Policies3/30/20234651.3 Rev. 2Office of ManagementPHS Commissioned Corps AwardsStaff Resources and Services10/10/20245022.0Office of Pharmaceutical QualityRoles and Responsibilities of FDA Liaisons to Standards Development OrganizationsRegulatory Review and Scientific Policies12/7/20225015.12 Office of Pharmaceutical QualityProcess for Evaluating Emerging Technologies Related to QualityRegulatory Review and Scientific Policies 11/29/20225100.6Office of Translational SciencePolicy and Procedures for Creating an Interest Group in the Office of BiostatisticsRegulatory Review and Innovation 6/23/20225019.2 Office of Pharmaceutical QualityAssessment of the Appropriate Net Container Content for Injectable Drug and Biological ProductsRegulatory Review and Scientific Policies12/5/20245223.6Office of Generic DrugsAssessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDAGeneric Drug Review6/7/20225220.3Office of Generic DrugsCommunicating Certain Deficiencies Identified During Filing Review of ANDAsGeneric Drug Review9/28/20175240.10Office of Generic DrugsClassifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development PurposesGeneric Drug Review4/13/20225019.1 Rev.1Office of Pharmaceutical QualityAllowable Excess Volume/Content in Injectable Drug and Biological ProductsRegulatory Review and Scientific Policies12/23/20246050.2 Rev. 1Office of ManagementEffect of Failure to Pay BsUFA FeesStaff Resources and Services10/05/20235021.1 Rev.1Office of Pharmaceutical QualityNaming of Drug Products Containing Salt Drug SubstancesRegulatory Review and Scientific Policies12/2/20225021.2Office of Pharmaceutical QualityEvaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAsRegulatory Review and Scientific Policies6/3/20214657.0 Rev.1Office of ManagementCDER's Time, Attendance, and Leave Recording PolicyStaff Resources and Services5/19/20217600.10Office of Strategic ProgramsCDER Master Data ManagementInformation Technology4/15/20227610.8Office of Strategic ProgramsElectronic and Digital Signatures for Records ManagementDrug8/12/20226720.4Office of Surveillance and EpidemiologyProcedures for Sharing Non-public Information on Pending Proposed Proprietary NamesDrug Safety9/21/20166030.3 Rev.1Office of New DrugsEmergency Investigational New Drug Application Process During and After Normal Business HoursNew Drug Review1/13/20255241.3 Rev.1Office of Generic Drugs and Office of Pharmaceutical QualityGood Abbreviated New Drug Application Assessment PracticesGeneric Drug Review10/6/20235240.3 Rev.6Office of Generic DrugsPrioritization of the Review of Original ANDAs, Amendments, and SupplementsGeneric Drug Review12/14/20225220.5 Rev.2Office of Generic DrugsIssuance of Information Requests and/or Discipline Review Letters for ANDAs under the Reauthorization of GDUFAGeneric Drug Review10/5/20225220.1Office of Generic DrugsReceiving and Processing a Request for Voluntary Withdrawal of an Approved ANDAGeneric Drug Review1/25/20235200.14 Rev.1Office of Generic DrugsFiling Review of Abbreviated New Drug ApplicationsGeneric Drug Review10/2/20235200.12Office of Generic Drugs and Office of Pharmaceutical QualityCommunicating Abbreviated New Drug Application Review Status Updates with IndustryGeneric Drug Review and Regulatory Review and Scientific Policies10/5/20225200.7 Rev.1Office of Generic DrugsANDA Amendments and Supplements Reviewed by the Division of Filing ReviewGeneric Drug Review11/29/20245016.6Office of Pharmaceutical QualityChange in Hard Gelatin Capsule SupplierRegulatory Review and Scientific Policies12/20/20245014.1 Rev.1Office of Pharmaceutical QualityUnderstanding CDER's Risk-Based Site Selection ModelRegulatory Review and Scientific Policies6/26/20235001.1Office of Pharmaceutical QualityDrug Product Distribution After a Complete Response Action to a Changes Being Effected SupplementRegulatory Review and Scientific Policies12/30/20244410.1 Rev. 2Office of CommunicationsFDA Pharmacy Student Experiential ProgramPublic Outreach7/28/20255242.1Office of Generic DrugsTransfer of OwnershipGeneric Drug Review8/26/20206701.4Office of Surveillance and EpidemiologyNotifying Applicants of Sentinel Analyses and ResultsDrug Review8/17/20206702.2Office of Surveillance and EpidemiologyDetermination of the Need for and Review of a New REMSDrug Review6/18/20205220.2 Rev.1Office of Generic DrugsConversion of ANDA Approval to Tentative Approval Because of Court OrderGeneric Drug Review12/8/20254121.3Office of the Center DirectorCollaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS)Leadership and Mission4/30/20206701.1Office of Surveillance and EpidemiologyProcedures for DMEPA Intra-Center Consult to DMPP on Patient-Oriented Labeling Submitted with Human Factors Validation Study ProtocolsDrug Safety9/18/20195220.8Office of Generic DrugsEvaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA MeetingsGeneric Drug Review10/5/20224191.1Office of New DrugsRisk Evaluation and Mitigation Strategies Modifications and RevisionsNew Drug Review7/1/20256004.3Office of New DrugsSafety Labeling Changes Under Section 505(o)(4) of the FD&C ActNew Drug Review11/07/20246720.5Office of Surveillance and EpidemiologyProcedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS ActDrug Safety3/7/20196701.3 Rev.1Office of Surveillance and EpidemiologyDevelopment of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and ProceduresDrug Safety10/28/20204000.1 Rev.6Office of ManagementDeveloping and Issuing MAPPs for CDERStaff Resources and Services9/9/20214112.2 Rev.1Office of Executive ProgramsSharing Nonpublic Information with Federal Government Officials.Regulatory Policy and Information Disclosure10/27/20224160.2 Rev.1Office of the Center DirectorPrioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory OrganizationsLeadership and Mission11/9/20227400.13 Rev. 2Office of New DrugsDetermining the Established Pharmacologic Class for Use in the Highlights of Prescribing InformationNew Drug Review7/21/20254200.1 Rev.1Office of the Center DirectorProcedures for Review of Protocols Referred By DEA That use Schedule I controlled Substances and DrugsLeadership and Mission11/12/20204200.2 Rev.2Office of the Center DirectorForecasting Schedule I and II Substance and Drug NeedsLeadership and Mission5/8/20244200.3 Rev.2Office of the Center DirectorConsulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug SchedulingDrug Safety10/26/20224601.3 Rev.2Office of ManagementChildren in the WorkplaceStaff Resources and Services1/22/20214516.1 Rev. 2Office of CommunicationsCriteria for Developing and Publishing Digital Content on the CDER External Web SitePublic Outreach7/21/20254512.2 Rev.2Office of Strategic ProgramsConducting Effective Meetings in CDER: Remote Access ConsiderationsInformation Technology12/8/20214510.2 Rev.2Office of Regulatory PolicyCDER Clearance of FDA Related Articles,Speeches and Other PublicationsRegulatory Policy and Information Disclosure9/17/20204510.1 Rev.2Office of CommunicationsCDER Process for Authorizing Staff to Participate in External EventsPublic Outreach11/25/20224520.1 Rev. 2Office of CommunicationsCommunicating Drug Approval InformationPublic Outreach11/10/20225017.1Rev.1Office of Pharmaceutical QualityOffice of Pharmaceutical Quality Assessment III and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA AssessmentsRegulatory Review and Scientific Policies12/2/20225015.7 Rev.1Office of Pharmaceutical QualityEnvironmental AssessmentsRegulatory Review and Scientific Policies11/23/20225015.6 Rev.1Office of Pharmaceutical QualityReview of Grouped Product Quality Supplements Regulatory Review and Scientific Policies12/9/20225015.5 Rev.1Office of Pharmaceutical QualityCMC Reviews of Type III DMF's for Packaging MaterialsRegulatory Review and Scientific Policies12/9/20225015.8Office of Pharmaceutical QualityAcceptance Criteria for Residual SolventsRegulatory Review and Scientific Policies12/1/20225016.1Office of Pharmaceutical QualityApplying ICH Q8(R2), Q9, and Q10 Principles to CMC ReviewRegulatory Review and Scientific Policies1/8/20255040.1Office of Pharmaceutical QualityProduct Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)Regulatory Review and Scientific Policies12/7/20225100.4 Rev.1Office of Translational SciencesScientific Interest Groups: Criteria and Policies.Regulatory Review and Innovation9/1/20215210.4 Rev 3Office of Generic DrugsAssessment of Bioequivalence Studies with Clinical Endpoints in ANDAsGeneric Drug Review4/28/20235210.5 Rev.3Office of Generic DrugsReview of Investigational New Drug Applications (Bio-INDs) by the Office of Generic DrugsGeneric Drug Review4/14/20225230.3 Rev.2Office of Generic DrugsGeneric Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic ActGeneric Drug Review12/13/20236020.4 Rev.3Office of New DrugsClassifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action LettersNew Drug Review10/21/20246020.2 Rev.1Office of New DrugsApplications for Parenteral Products in Plastic Immediate ContainersNew Drug Review12/19/20236010.9 Rev.1Office of New DrugsProcedures and Responsibilities for Developing Postmarketing Requirements and CommitmentsNew Drug Review4/13/20266010.8 Rev.2Office of New DrugsNDAs and BLAs: Communication to Applicants of Planned Review TimelinesNew Drug Review9/19/20246010.5Office of New DrugsNDAs: Filing Review IssuesNew Drug Review3/27/20186010.2 Rev. 2Office of New DrugsResponsibilities for Tracking and Communicating the Status of Postmarketing Requirements and CommitmentsNew Drug Review4/13/20265210.9 Rev.1Office of Pharmaceutical QualityReview of Botanical Drug ProductsRegulatory Review and Scientific Policies1/21/20224190.1 Rev.4Office of the Center Director

Drug Shortage Management

• Medical Necessity Determination Form (PDF - 786 KB)

Medical Policy2/1/20246001.1 Rev. 1Office of Executive ProgramsSpecial Government Employees Representing Sponsors Before CDERExecutive Secretariat9/16/20225310.7 Rev.1Office of Pharmaceutical QualityAcceptability of Standards From Alternative Compendia (BP/EP/JP)Regulatory Review and Scientific Policies9/18/20245310.3 Rev.2Office of Pharmaceutical QualityRequests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls ChangesRegulatory Review and Scientific Policies12/19/20246030.1 Rev.3Office of New DrugsIND Clinical HoldsNew Drug Review2/20/20186020.8 Rev 1Office of New DrugsNDAs/BLAs/Efficacy Supplements: Action Packages and Taking Regulatory ActionsNew Drug Review6/14/20166020.5 Rev. 2Office of New DrugsGood Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug ProductsNew Drug Review6/25/20187600.6 Rev. 2Office of Strategic ProgramsRequesting and Accepting Non-Archivable Records in Electronic Format for New Drug ApplicationsInformation Technology4/24/20237400.1 Rev. 2Office of New DrugsManagement of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working GroupsNew Drug Review5/17/20166720.2 Rev. 2Office of Surveillance and EpidemiologyProcedures for Handling Requests for Proprietary Name ReviewDrug Safety8/8/20246700.5Office of Surveillance and EpidemiologyResponding to Requests For Waivers of Postmarketing Safety Reporting Requirements under 21 CFR §§ 314.80 (NDAs), 314.98 (ANDAs), and 600.80 (BLAs)Drug Safety7/25/20226700.9 Rev. 2Office of Surveillance and EpidemiologyFDA Posting of New Safety Information or Potential Signals of Serious Risks Identified in the FDA Adverse Event Reporting SystemDrug Safety12/31/20256610.1 Rev. 2Office of Translational Sciences and BiostatisticsStatistical Policy CouncilRegulatory Review and Innovation6/1/20216050.1 Rev. 2Office of ManagementEffect of Failure to Pay PDUFA FeesStaff Resources and Services12/01/20216030.8 Rev. 1Office of New DrugsINDs: Exception from Informed Consent Requirements for Emergency ResearchNew Drug Review11/17/20146030.6Office of New DrugsINDs: Processing Treatment INDs and Treatment ProtocolsNew Drug Review12/9/20116030.2 Rev.2Office of New DrugsINDs: Review of Informed Consent DocumentsNew Drug Review7/18/20256020.3 Rev.2Office of New DrugsReview Designation Policy: Priority (P) and Standard (S)New Drug Review6/25/20135240.5 Rev.3Office of Generic DrugsANDA Suitability PetitionsGeneric Drug Review9/29/20237620.6 Rev.1Office of the Center DirectorProcedure for Review and Clearance of ICH GuidelinesInformation Technology3/19/20247610.6 Rev.1Office of Strategic ProgramsCDER Electronic Application Forms OversightInformation Technology10/7/20226025.4 Rev.1Office of New DrugsGood Review Practice: Refuse to FileNew Drug Review10/23/20257412.1 Rev.2Office of New DrugsManagement of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee ProceedingsNew Drug Review6/8/20187412.2 Rev.1Office of New DrugsManagement of CDER Carcinogenicity Assessment Committee and Communication of Committee ProceedingsNew Drug Review6/7/20186025.6 Rev.1Office of New DrugsGood Review Practice: Management of Breakthrough Therapy-Designated Drugs and BiologicsNew Drug Review2/28/20245016.3
Rev. 1Office of Pharmaceutical QualityResponsibility for the Quality Assessment of Products Containing Peptide or Protein Drug SubstancesRegulatory Review and Scientific Policies6/21/20237600.11Office of Strategic ProgramsCDER Electronic Record Keeping SystemsInformation Technology8/4/20214100.1 Rev.2Office of ManagementCDER Co-Sponsorship Agreements for EventsStaff Resources and Services6/21/20227700.5 Rev.1Office of Translational SciencesCritical Path Innovation Meetings Policy and ProceduresRegulatory Review and Innovation4/14/20214001.1Office of ManagementDeveloping, Issuing and Maintaining Standard Operating Procedures for CDERStaff Resources and Services2/1/20236025.7 Rev.1Office of New DrugsGood Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics That Are Receiving an Expedited ReviewNew Drug Review 2/28/20244651.4 Rev.1Office of ManagementCDER Incentive Awards Program (Cash and Time-off)Staff Resources and Services7/16/20204800.2 Rev.1Office of the Center DirectorContinuity of Operations (COOP)Leadership and Mission7/21/20217610.7 Rev.1Office of Strategic ProgramsCDER Data Standards ProgramInformation Technology8/31/20215241.2 Rev. 1Office of Generic DrugsConsolidation of ANDAs by the Office of Generic DrugsGeneric Drug Review8/19/20206001.2 Rev.2Office of CommunicationsCDER Network Of ExpertsLeadership and Mission2/1/20245018.2Office of Pharmaceutical QualityNDA Classification CodesRegulatory Review and Scientific Policies12/6/2022