Bioequivalence and Bioavailability Forum 05:16 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Siddheshwar Shinde
Junior

India,
2018-03-21 11:07

Posting: # 18575
Views: 1,441
 

 Different sources of Prescribing Information [Regulatives / Guidelines]

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.
Ohlbe
Hero

France,
2018-03-21 18:14

@ Siddheshwar Shinde
Posting: # 18577
Views: 1,237
 

 Different sources of Prescribing Information

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
Siddheshwar Shinde
Junior

India,
2018-03-23 05:23

@ Ohlbe
Posting: # 18586
Views: 1,117
 

 Different sources of Prescribing Information

» 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]
jag009
Hero

NJ,
2018-03-22 19:11

@ Siddheshwar Shinde
Posting: # 18583
Views: 1,164
 

 Different sources of Prescribing Information

I use the product monograph from the manufacturer (FDA studies). Drugs@FDA is my alternate source.
J
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,939 posts in 4,040 threads, 1,288 registered users;
online 14 (0 registered, 14 guests [including 5 identified bots]).

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed