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Siddheshwar Shinde ☆ India, 2018-03-21 12:07 (2591 d 05:57 ago) Posting: # 18575 Views: 3,689 |
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Two different sources available for Prescribing Information (PI). 1. Drugs@FDA: FDA Approved Drug Products 2. DAILYMED (U.S. National Library of Medicine) Drugs@FDA has last approved PI and posted by the Food and Drug Administration (FDA) itself. The drug labeling information on DAILYMED is the most recent PI (different than FDA approved labeling) submitted (by firms) to FDA but labeling changes have not been approved by FDA. Among these sources, which source of Prescribing Information being used during conduct of clinical study considering the safety and other concerns. |
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Ohlbe ★★★ France, 2018-03-21 19:14 (2590 d 22:50 ago) @ Siddheshwar Shinde Posting: # 18577 Views: 3,009 |
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Dear Siddheshwar, ❝ Two different sources available for Prescribing Information (PI). Oh, there are actually much more than 2, if you also look outside of the USA... ❝ Among these sources, which source of Prescribing Information being used during conduct of clinical study considering the safety and other concerns. Well, use for what purpose ? When you prepare the information form for the subjects: I would suggest you to also look at the information approved in India, not just in the USA, Europe or wherever... Use the most complete list to inform the subjects. You may actually combine information from several official sources to prepare your information form and make it as complete and comprehensive as possible. Keep all documents used as source in the TMF. To determine whether SAEs are expected or not (and therefore could be a SUSAR requiring expedited reporting), if you are the sponsor or if the sponsor delegated this task to you: only approved information should be used, not information submitted but not yet approved. But if you run your trial in India, wouldn't the CDSCO expect you to use the information they have approved, rather than the FDA's ? — Regards Ohlbe |
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Siddheshwar Shinde ☆ India, 2018-03-23 06:23 (2589 d 11:41 ago) @ Ohlbe Posting: # 18586 Views: 2,882 |
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❝ Oh, there are actually much more than 2, if you also look outside of the USA... My RLD is from US so I'm referring FDA approved PI. ❝ When you prepare the information form for the subjects: I would suggest you to also look at the information approved in India, not just in the USA, Europe or wherever... Use the most complete list to inform the subjects. yes sure. ❝ You may actually combine information from several official sources to prepare your information form and make it as complete and comprehensive as possible. Keep all documents used as source in the TMF. There is need to refer correct source for warning and precautions, adverse reactions, interactions etc. ❝ To determine whether SAEs are expected or not (and therefore could be a SUSAR requiring expedited reporting), if you are the sponsor or if the sponsor delegated this task to you: only approved information should be used, not information submitted but not yet approved. But if you run your trial in India, wouldn't the CDSCO expect you to use the information they have approved, rather than the FDA's ? Agreed. If I'm submitting the case study in specific regulatory other than CDSCO, then I've to refer official approved source wrt RLD. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
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jag009 ★★★ NJ, 2018-03-22 20:11 (2589 d 21:53 ago) @ Siddheshwar Shinde Posting: # 18583 Views: 2,951 |
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I use the product monograph from the manufacturer (FDA studies). Drugs@FDA is my alternate source. J |
Ing. Helmut Schütz