D2S02-Johnson-v1.2-FINAL.pdf

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1、Letters of Authorization-What FDA Wants You to KnowDeborah F Johnson,Ph.D.SupervisorOPQAIII Div XIXCDER|US FDAGDF 2026-Apr 23rd2026www.fda.govwww.fda.gov2Intro What is a letter of authorization(LOA)LOA Basics Importance of an LOA Keeping things up to datewww.fda.govwww.fda.gov3Drug Master Files(DMF)

2、Confidential submission from a DMF holder to the Agency Information on manufacturing processes,control strategies,facilities,etc.May support INDs,A/NDAs,or another DMF A DMF is not required by law FDA cannot access without a Letter of Authorizationwww.fda.govwww.fda.gov421 CFR 314.420(d)and DMFs The

3、 DMF must have a complete list of parties authorized to reference Must identify the information that each party is authorized to incorporate May authorize for all drug products from a party,or may restrict to particular drug productswww.fda.govwww.fda.gov5What is a Letter of Authorization(LOA)A form

4、al signed document from a DMF holder The permission FDA needs to reference confidential information in a DMF to support an IND,A/NDA or DMF Prevents disclosure of the information to 3rdpartieswww.fda.govwww.fda.gov6Basics for LOA Must be on company letterhead Must identify The specific DMF number Pr

5、oduct/process/facility that is being authorized The authorized partyRemember!A separate LOA is required for each authorized partywww.fda.govwww.fda.gov7Submitting an LOA An LOA must be submitted directly to the DMFAND The same LOA must be submitted to the referencing application or referencing DMF/I

6、ND Do you still need an LOA if the DMF and referencing party are from the same company?YESwww.fda.govwww.fda.gov8Dont make FDA search for your LOAswww.fda.govwww.fda.gov9Where to put the LOA If you are a DMF holder LOAs should be placed in eCTD Section 1.4.1 LOAs for parties referencing your DMF LOA