| Comment Record|
Ms. Becky Armfield ||
2002-01-09 11:06:37 |
Novartis Animal Health |
| Comments for FDA General |
1. General Comments
In reading guidances 142 and 117, it appears that PSUs are the same, with a few additions, as what was previously called the Drug Experience Report (DER) in the US. Is this the case? If so, will the US continue to refer to the annual report as a DER? Much of the same information that's required in the PSU is already submitted in the annual DERs, including sponsor information, individual periodic AERs, scientific article abstracts, sales volume, and packaging (including labels). Will this guideline require all this information to be submitted again in a separate and additional report on every VMP yearly?
Page 3, Timing of Reporting
This timing issue should be resolved prior to the implementation of this guideline. If this issue is not resolved, an undue burden will be placed on sponsors with approvals in multiple countries.
Page 4, 1. 1.4Sender of the PSU and VMP identification
When a VMP is updated (e.g. a change in formulation) are separate PSU's required or can the information be combined into one PSU with sections for each formulation (e.g. swallow tabs, flavor tabs, and flavor coated tabs)?
Page 4, 2. Individual AERs
This same information is submitted on the FDA 1932 forms. Can we conclude that the US will continue to use the current 1932 form? For global AERs, will regional forms be acceptable if they meet the minimum requirements? Should the global AERs be included in the US summary or summarized separately? Will a standard reporting format be provided for the summary?
Page 4, 3. Safety and Efficacy Citations
Will Medline abstracts fulfill this requirement or must each article include its own summary?
Page 4, 4. Sales Volume
Will US MAHs be required to report global sales to enable an incidence-calculation of global AERs? Will a standard format be provided for reporting sales volume?
Page 5, 7. Narrative review of AERs and an Overall Safety Evaluation
Define a suitably qualified expert for pharmacovigilance. Can this be an employee of the MAH or must it be an outside expert? If an outside expert is required, there is a risk to proprietary information.