-Drug Master File- Project Management Perspective. CDR Kun Shen, Pharm.D., M.S., BCPS

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1 -Drug Master File- Project Management Perspective CDR Kun Shen, Pharm.D., M.S., BCPS

2 Disclaimer & Disclosure Views presented are those of the speaker and do not reflect official FDA, DHHS or other government opinion or policy. I have nothing to disclose. 2

3 Type II API DMF in the - post GDUFDA world General Comments Communication Completeness Assessment (CA) No Further Comment (NFC) Easily Correctable Deficiencies (ECD) Complete Response (CR) Meeting Request (MR) 3

4 DMF - General Comments Encourage electronic submission to expedite the review process Once a DMF is submitted electronically, all subsequent submissions must be electronic as well, no mixed submissions A Letter of Authorization (LOA) is required for CMC review even if the DMF holder is the same company as the authorized party. If the primary DMF is referencing a secondary DMF for information, the primary DMF should contain the LOA issued by the secondary DMF holder and the secondary DMF should be active website: onrequirements/drugmasterfilesdmfs/default.htm 4

5 Communication The DMF Staff provides support for 18 Chemistry Review Teams in OGD DMF Division has total 29 reviewers (and growing) Will have three PMs (Dr. Kun Shen, Dr. Maria Cowan, and Dr. Mandy Kwong) Main contacts are DMF Project Managers (PMs) Prefer to communicate via . Direct all inquiries to: DO NOT call or reviewers directly. Starting January 2014, all submission notifications should be sent to: 5

6 Status Request Under Review, Under Review, Under Review PMs will provide a time frame for you to check back. For full CMC reviews If a review has been picked up for review 3 months If a review has not been picked up 6 months For CA reviews, please DMFOGD@fda.hhs.gov Please wait 2 months after your DMF payment before calling for CA status if you don t see your DMFs list on the Available For Reference List. 6

7 Seeking Guidance? your inquiry to We will determine the best way to respond Written response via Telephone Conference 7

8 Completeness Assessment (CA) Available for Reference List will be updated once a week No guidance on time to respond to CA deficiencies Your action or inaction will affect the filing of the ANDA that references your DMF Starting in third year of GDUFA, Incomplete CA may delay the filing date of the ANDA until the date CA is complete 8

9 Completeness Assessment (New) DMF PMs will provide CA status to ANDA holder if DMF does not pass CA review and it has been referenced by a pending ANDA Please also note that the drug product applicant who references your DMF has been notified that your DMF is Incomplete in its current form. Failure to timely respond to the following requests may result in RTR (Refuse to Receive) of the referencing ANDA and partial loss of the ANDA application fee. A courtesy will be sent to ANDA applicant as FYI ANDA applicant and DMF holder will be contacted again later when the ANDA is up for filing decision and DMF holder has not responded to our CA deficiencies 9

10 No Further Comment (NFC) Letter DMF holder will receive a NFC Letter every time a referenced ANDA is approved or tentatively approved Exception: If an ANDA is approved with an outstanding DMF Information Request, a NFC letter will not be sent until Information Request response is received Does not imply that the information is sufficient to support any other ANDA Does not imply that the information will remain sufficient in the future DMF holders are obligated to report any future changes to the DMF and to notify your coustomers, as required under 21 CFR (c) 10

11 DMF Easily Correctable Deficiency (ECD) ECD- missing information, clarification, or minor deficiencies in which the applicant may provide a complete and satisfactory response within 10 business days of the request DMF reviewer may choose to send you an to convey the ECDs. The firm has 10 business days to respond Failure to respond will result in a CR FDA may also choose to issue DMF Information Request (IR) for DMF ECDs 11

12 DMF Complete Response (CR) Letter detailing ALL identified deficiencies from all relevant review disciplines. Includes inspections information Includes consults with other agencies (if any) 12

13 Post CR Meeting Request (MR) DMF holders may request a 30 minute teleconference to discuss the deficiencies listed in the CR DMFOGD@fda.hhs.gov for MR instructions 1 st Cycle Post CR MR should be submitted within 10 business days of issuance of the CR Priority is given to MR that is received in 10 days or the API is referenced by an expedited ANDA MR Must be limited to the content of the CR Which deficiency What are your concerns Must be submitted to the Central Document Room Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville, MD

14 Post CR Meeting Request (MR) Should title clearly Post Complete Response Meeting Request Please notify the DMF PMs via after a MR is submitted DMFOGD@fda.hhs.gov FDA shall grant or deny the request in a reasonable time frame. Outcome may include: Grant teleconference Grant written response Deny respond with rationale 14

15 Post CR Meeting Request If a Teleconference is granted, the DMF PM will schedule a meeting as soon as we can Due to MR volume, DMF PMs may not preside at every meeting MF holder may be asked to take meeting minutes and share with FDA FDA will generate meeting minutes for official archive 15

16 Questions? 16