Deleted Tweets From Scott Gottlieb, R-D.C.

Similarly, within CBER, work on whole blood, blood components for transfusion, allergenic extract products, and human cells, tissues, and tissue-based products regulated solely under section 361 of the Public Health Service Act cannot be conducted with carryover user fee funding.

During the lapse period, FDA will not perform any activities with respect to these medical products except for emergency work involving the safety of human life or the protection of property.

If a sponsor sends #FDA a non-emergency IND during the lapse period for a medical product in one of these categories, the 30-day review clock will not start until the lapse period is over.

Additionally, for medical products in these categories subject to premarket approval, FDA will suspend review of any pending regulatory submissions unless the submission is: an emergency IND; or an IND amendment related to the safety of human subjects (e.g. an IND safety report)

I will post some shutdown-related updates and more specific guidance on the device, animal drug, and biosimilars programs tomorrow.

The only new INDs and IND amendments for these products that FDA will consider “received” (and proceed to review) during the lapse period are: new emergency INDs; and new IND amendments that relate to the safety of human subjects.

It also includes applications for which FDA has waived the application fee (e.g., small business waiver) and NDAs or BLAs that only have orphan designated indications.

THREAD: To clarify, regarding some questions I'm getting on Twitter: During the shutdown, for PDUFA products, FDA will accept new regulatory submissions for which no fee is required. This includes submissions that fall within the fee exemption for previously filed applications.

In general, PDUFA-covered products are products that would be approved under an NDA—including a 505B2 application—or a 351(a) BLA.

@SarahKarlin For PDUFA-related products FDA will accept and work on new regulatory submissions for which no fee is required. These include INDs. But for not user-fee related products we can't perform work on an IND unless it's excepted activity such as an emergency IND (compassionate use IND)

Products that would be approved under an ANDA or 351(k) biosimilar BLA are not PDUFA-covered products. Nor are OTC monograph drugs, although OTC products approved under NDAs are PDUFA-covered.

Hope this is helpful. We will try to answer additional queries in a timely way and will be posting more general Q&As.

Medical gases that have been deemed to have NDAs through the medical gas certification process outlined in sections 575 and 576 of the FDCA are also PDUFA-covered products.

@BRAVEmediaMO @Vapingit There's a mute button????

During the lapse period, #FDA can't accept PDUFA applications that require the payment of a fee - for example, New Drug Applications (NDAs) or certain Biologics License Applications (BLAs) - because it can't accept new FY2019 user fees without an appropriations bill for FY2019.

I’m grateful for the thousands of #FDA employees who continue work on vital public health activities during the lapse in funding, such as drug shortages mitigation for life-sustaining drugs, food outbreaks, and surveillance of adverse events reports that could cause human harm.

We’re fortunate that many employees can continue work for the immediate future mostly because of carryover user fees. User fees support approvals of new medical products, our ability to review requests to conduct important clinical research, and issue certain guidance documents.

We know the shutdown imposes hardships on our workforce. We're taking steps to try and mitigate personal impacts wherever we can. I'm grateful for the continued contributions of employees who are working through the shutdown, as well as the commitment of those who are furloughed.

I’ve heard from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA. I want to be very clear - I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon https://t.co/0xQuXnSPbo

1/2 We’re alerting consumers and health care providers that Torrent is expanding its voluntary recall of losartan potassium tablets to include 8 more lots (10 total) due to trace amounts of NDEA impurity above the acceptable level in the API https://t.co/qNsSYgdXLS

Similarly, within CBER, work on whole blood, blood components for transfusion, allergenic extract products, and human cells, tissues, and tissue-based products regulated solely under section 361 of the Public Health Service Act cannot be conducted with carryover user fee funding.

During the lapse period, FDA will not perform any activities with respect to these medical products except for emergency work involving the safety of human life or the protection of property.

If a sponsor sends #FDA a non-emergency IND during the lapse period for a medical product in one of these categories, the 30-day review clock will not start until the lapse period is over.

Additionally, for medical products in these categories subject to premarket approval, FDA will suspend review of any pending regulatory submissions unless the submission is: an emergency IND; or an IND amendment related to the safety of human subjects (e.g. an IND safety report)

I will post some shutdown-related updates and more specific guidance on the device, animal drug, and biosimilars programs tomorrow.

The only new INDs and IND amendments for these products that FDA will consider “received” (and proceed to review) during the lapse period are: new emergency INDs; and new IND amendments that relate to the safety of human subjects.

It also includes applications for which FDA has waived the application fee (e.g., small business waiver) and NDAs or BLAs that only have orphan designated indications.

THREAD: To clarify, regarding some questions I'm getting on Twitter: During the shutdown, for PDUFA products, FDA will accept new regulatory submissions for which no fee is required. This includes submissions that fall within the fee exemption for previously filed applications.

In general, PDUFA-covered products are products that would be approved under an NDA—including a 505B2 application—or a 351(a) BLA.

@SarahKarlin For PDUFA-related products FDA will accept and work on new regulatory submissions for which no fee is required. These include INDs. But for not user-fee related products we can't perform work on an IND unless it's excepted activity such as an emergency IND (compassionate use IND)

Products that would be approved under an ANDA or 351(k) biosimilar BLA are not PDUFA-covered products. Nor are OTC monograph drugs, although OTC products approved under NDAs are PDUFA-covered.

Hope this is helpful. We will try to answer additional queries in a timely way and will be posting more general Q&As.

Medical gases that have been deemed to have NDAs through the medical gas certification process outlined in sections 575 and 576 of the FDCA are also PDUFA-covered products.

@BRAVEmediaMO @Vapingit There's a mute button????

During the lapse period, #FDA can't accept PDUFA applications that require the payment of a fee - for example, New Drug Applications (NDAs) or certain Biologics License Applications (BLAs) - because it can't accept new FY2019 user fees without an appropriations bill for FY2019.

I’m grateful for the thousands of #FDA employees who continue work on vital public health activities during the lapse in funding, such as drug shortages mitigation for life-sustaining drugs, food outbreaks, and surveillance of adverse events reports that could cause human harm.

We’re fortunate that many employees can continue work for the immediate future mostly because of carryover user fees. User fees support approvals of new medical products, our ability to review requests to conduct important clinical research, and issue certain guidance documents.

We know the shutdown imposes hardships on our workforce. We're taking steps to try and mitigate personal impacts wherever we can. I'm grateful for the continued contributions of employees who are working through the shutdown, as well as the commitment of those who are furloughed.

I’ve heard from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA. I want to be very clear - I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon https://t.co/0xQuXnSPbo

1/2 We’re alerting consumers and health care providers that Torrent is expanding its voluntary recall of losartan potassium tablets to include 8 more lots (10 total) due to trace amounts of NDEA impurity above the acceptable level in the API https://t.co/qNsSYgdXLS