What is PADER?
Periodic Adverse Drug Experience Report (PADER/PAER) is aggregate safety reports required from MAH to be submitted consisting of ICSR submission and their analysis by FDA as per guidance 314.80 (c) and 600.80 (c) (2).
Why is it needed?
PADER serves the purpose of collating, updating, evaluating, and providing a summary of post-approval information of a product along with its benefit-risk profile evaluation.
The key difference is a detailed analysis is not required as per PBRER/PSUR format. Only mention about labelling changes already performed are added. But the actual analysis done during the current PADER and if this data led to changes in labeling of product or if additional investigations are required for any of the new/existing risks mentioned for products is dealt separately and not mentioned.
When is it needed?
For the first three years, the company needs to submit the report quarterly and, thereafter, annually upon obtaining approval from the FDA.
MAH must submit Quarterly PADER within 30 days of the close of the quarter beginning from first quarter from date of approval.
MAH must submit Annual report within 60 days of the anniversary date of approval of the application.
Waiver not to submit PADER
An MAH can take waiver from FDA and update the NDA listing and submit PBRER/PSUR instead of PADER in ICH regions.
Key points for drafting PADER
1.Ensure all the ICSR are already submitted during the review period (15 day reports), and their submission dates are entered in safety database. If any ICSR not submitted then MAH need to submit it ASAP and initiate CAPA as per internal process.
2. The cases/ICSR that are going to be submitted as part of PADER are closed in safety database to generate their XML’s.
3. The ICSR that needs description should be 15 day expedited cases along with their clinical significance. Narrative should be brief, with emphasis on data only about serious and unlisted event, hence avoid copy and paste of narratives. Company comments explaining MAH causality of case should be retained.
4. Explain the 15 day expedited and other cases in brief manner and corelate their significance in terms of impact on benefit-risk profile of product.
5. Attaching the recent USPI and describing a very briefly what were the changes in USPI made during review period. Adding any postmarking studies, regulatory actions and any new safety measures implemented in respective sections.
References:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.80
Written by:
Dr.Shraddha Bhange.
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