Regulatory Open Forum

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

In what ways would harmonized processes and standards for understanding baseline healthy microbiota promote development of strategies for nutrition and clinical applicability?

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

In what ways would harmonized processes and standards for understanding baseline healthy microbiota promote development of strategies for nutrition and clinical applicability?

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Could you talk more about efforts to establish a baseline and standards for comparison of the human microbiome to help the understanding of what constitutes a 'normal' microbiome?

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Question for Jen Multari: You mentioned in your article that your team would be considering a 'follow-the-sun' approach to publishing this year to address shorter time to submission and flexibility and scalability. Could you talk more about the 'follow-the-sun' approach and share any updates you might have on the rollout?

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Here is one scenario that I would want to hear others' opinions on:

This is about a new drug submission of a generic drug that will come off patent during the review, therefore getting the Marketing Authorization with

the least number of requests from the regulator is crucial.

The regulations indicate that the dossier needs to include at a minimum 6 months of Room Temperature data.

The RA head knows that the data will not be available on time for the target date for submission.

We assume that the product will have passing results at the end of the 6 months.

The RA head decides to keep the filing date of the dossier with this strategy:

1. dossier is submitted with empty nodes for the 6 M RT  data– it contains passing results for the 3 M accelerated that is provided in the dossier.

    The node can't be empty. It will fail validation at the regulator's end of the electronic transmission

    The company receives a validation failure notification and is asked to re-submit the complete electronic dossier as soon as possible.

    The dossier is resubmitted after – let's say – 3 business days, that include a week-end.

2. The complete electronic dossier is sent with the "wrong batch" 6 M RT data

    This is caught by the regulator's reviewer during the screening – a screening deficiency notice is issued to respond to in 45 calendar days.

3. Finally, the correct, passing, RT 6 M data is provided in a subsequent sequence of the eCTD dossier almost 2 months later that it should have been.

Question for the RA people:

Would you do this?

Please tell us why, for both yes and no answers.

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Also for Jen:

Has having Project BRIDGE in place helped your company deal with the disruptions caused by the pandemic? If so, how, and have you had to make any adjustments?

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Could you discuss the regulatory needs relating to microbiomes, specifically the regulatory framework, harmonization, safety etc, and outcome benefits?

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie

Hi RegEx members,

Recently, RAPS released its' quarterly Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. We will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM ET here on RegEx. We will have two regulatory experts, @Jennifer Multari and @Manfred Ruthsatz, who will be discussing the articles in real-time and available to answer your questions.

If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.

Looking forward to seeing your questions!

Best,
Annie