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

RT @SeanKhozin: Congratulations to Dr. Farrell of ⁦@FDAOncology⁩ for receiving the #ASH2018 Outstanding Service Award today for her… https://t.co/JzBtRaLGXs

RT @FDAfood: Thinking about leftovers? Learn about food product dating & how long you can safely store various foods in pantry,… https://t.co/fj8sUd5sDt

RT @califf001: Great string on real world data & evidence. right on target. Critical to understand that RWE INCLUDES randomization as a to… QT @SGottliebFDA: Our goal is to close the evidence gap between the information we use to make #FDA’s decisions and the evidence used… https://t.co/vWiOZHt6tH)

RT @FDAfood: Whaaaat? �My tablet, cell phone, & laptop could be a #foodsafety hazard? Check out findings of a recent FDA analysi… https://t.co/SQDru1Nb5L

RT @modrnhealthcr: FDA looks to revamp medical device approval pathway https://t.co/iT44PdnzhL https://t.co/StgO2T1rmD

Over last decade there’s been a 46% increase in annual number of device inspections (from about 2000 inspections in 2007 to 2952 in 2017) and a 243% increase in annual number of foreign device inspections during the same period, leading to more compliance https://t.co/wQhrTVHo6u https://t.co/dlw5b40bJh

THREAD: New #FDA draft guidance issued today is aimed at accelerating the development of safe and effective treatments for NASH by, among other things, outlining opportunities to use histological changes as a potential surrogate for measuring improvement. https://t.co/i0W4GXIWNR

In recent years, considerable progress has been made in the research and development of new treatments for NASH, but a lot of work remains to be done when it comes to improving medical care for patients. Our new guidance is aimed at advancing these opportunities more efficiently.

RT @HHSGov: Not sure if it's a cold or the flu? @CDCgov shows how you can tell the difference. https://t.co/ptcFVgUEdp https://t.co/4ncrWypCUi

The ultimate goal of a treatment for NASH is to slow, halt, or reverse the progression of disease and improve clinical outcomes. This can be done by preventing progression to cirrhosis and cirrhosis complications, reducing the need for liver transplantation and improving survival

Because of the slow progression and time required to do trials to evaluate clinical endpoints such as survival, the FDA is outlining a path for considering improvements in liver histology as endpoints reasonably likely to predict clinical benefit to support accelerated approval.

Looking at changes in histology can also offer more opportunities for developing therapies that can intervene earlier in the disease to mitigate or reverse its effects. These can include new medicines that help arrest or resolve the progression of steatohepatitis and fibrosis.

The guidance also encourages sponsors to identify new biochemical or noninvasive imaging biomarkers that could eventually replace liver biopsies for monitoring progress and improvement, and that can be used for patient selection or for assessing efficacy in clinical trials.

This guidance is part of our broader effort to foster the efficient development of safe and effective treatments for addressing serious, unmet medical needs. We've devoted considerable new resources to creating additional, disease-focused guidance documents aimed at unmet needs.

RT @FDASpox: REPORTERS: Today #FDA released a new video resource to help industry & consumers understand menu labeling regs. It… https://t.co/JrudKi98bc

RT @FDAOncology: 2018 saw 32 #FDAapprovals in #hematology including 12 NMEs & 5 #biosimilars. 8 had pediatric indications. 6 were fo… https://t.co/9WEzAHvSef

The hundreds of new disease focused guidance documents that we've committed to develop in the coming years are part of our larger modernization of the Office of New Drugs; and our commitment to developing more efficient, science-based criteria for advancing beneficial treatments.

RT @tmprowell: #Advocacy roll call—who’s coming to lunch? If you’re a patient advocate & you’ll be at #SABCS18, you’re invited! https://t… QT @tmprowell: Excited for @FDAOncology meeting w/ breast cancer pt advocates at #SABCS18 on Thurs 12/6/18 12-1p CST in Conv Ctr R… https://t.co/QQU9wgpnPv)

RT @FDAPatientinfo: New #RFA from #FDA Office of Orphan Products to support Natural History studies. Applications due Jan 2019. More in… https://t.co/iZ9jeIAFw4

RT @InHealthPolicy: FDA Clarifies Procedures For Generics To Request Meetings Post-CRL https://t.co/rS2l1YJIG7

RT @SeanKhozin: Congratulations to Dr. Farrell of ⁦@FDAOncology⁩ for receiving the #ASH2018 Outstanding Service Award today for her… https://t.co/JzBtRaLGXs

RT @FDAfood: Thinking about leftovers? Learn about food product dating & how long you can safely store various foods in pantry,… https://t.co/fj8sUd5sDt

RT @califf001: Great string on real world data & evidence. right on target. Critical to understand that RWE INCLUDES randomization as a to… QT @SGottliebFDA: Our goal is to close the evidence gap between the information we use to make #FDA’s decisions and the evidence used… https://t.co/vWiOZHt6tH)

RT @FDAfood: Whaaaat? �My tablet, cell phone, & laptop could be a #foodsafety hazard? Check out findings of a recent FDA analysi… https://t.co/SQDru1Nb5L

RT @modrnhealthcr: FDA looks to revamp medical device approval pathway https://t.co/iT44PdnzhL https://t.co/StgO2T1rmD

Over last decade there’s been a 46% increase in annual number of device inspections (from about 2000 inspections in 2007 to 2952 in 2017) and a 243% increase in annual number of foreign device inspections during the same period, leading to more compliance https://t.co/wQhrTVHo6u https://t.co/dlw5b40bJh

THREAD: New #FDA draft guidance issued today is aimed at accelerating the development of safe and effective treatments for NASH by, among other things, outlining opportunities to use histological changes as a potential surrogate for measuring improvement. https://t.co/i0W4GXIWNR

In recent years, considerable progress has been made in the research and development of new treatments for NASH, but a lot of work remains to be done when it comes to improving medical care for patients. Our new guidance is aimed at advancing these opportunities more efficiently.

RT @HHSGov: Not sure if it's a cold or the flu? @CDCgov shows how you can tell the difference. https://t.co/ptcFVgUEdp https://t.co/4ncrWypCUi

The ultimate goal of a treatment for NASH is to slow, halt, or reverse the progression of disease and improve clinical outcomes. This can be done by preventing progression to cirrhosis and cirrhosis complications, reducing the need for liver transplantation and improving survival

Because of the slow progression and time required to do trials to evaluate clinical endpoints such as survival, the FDA is outlining a path for considering improvements in liver histology as endpoints reasonably likely to predict clinical benefit to support accelerated approval.

Looking at changes in histology can also offer more opportunities for developing therapies that can intervene earlier in the disease to mitigate or reverse its effects. These can include new medicines that help arrest or resolve the progression of steatohepatitis and fibrosis.

The guidance also encourages sponsors to identify new biochemical or noninvasive imaging biomarkers that could eventually replace liver biopsies for monitoring progress and improvement, and that can be used for patient selection or for assessing efficacy in clinical trials.

This guidance is part of our broader effort to foster the efficient development of safe and effective treatments for addressing serious, unmet medical needs. We've devoted considerable new resources to creating additional, disease-focused guidance documents aimed at unmet needs.

RT @FDASpox: REPORTERS: Today #FDA released a new video resource to help industry & consumers understand menu labeling regs. It… https://t.co/JrudKi98bc

RT @FDAOncology: 2018 saw 32 #FDAapprovals in #hematology including 12 NMEs & 5 #biosimilars. 8 had pediatric indications. 6 were fo… https://t.co/9WEzAHvSef

The hundreds of new disease focused guidance documents that we've committed to develop in the coming years are part of our larger modernization of the Office of New Drugs; and our commitment to developing more efficient, science-based criteria for advancing beneficial treatments.

RT @tmprowell: #Advocacy roll call—who’s coming to lunch? If you’re a patient advocate & you’ll be at #SABCS18, you’re invited! https://t… QT @tmprowell: Excited for @FDAOncology meeting w/ breast cancer pt advocates at #SABCS18 on Thurs 12/6/18 12-1p CST in Conv Ctr R… https://t.co/QQU9wgpnPv)

RT @FDAPatientinfo: New #RFA from #FDA Office of Orphan Products to support Natural History studies. Applications due Jan 2019. More in… https://t.co/iZ9jeIAFw4

RT @InHealthPolicy: FDA Clarifies Procedures For Generics To Request Meetings Post-CRL https://t.co/rS2l1YJIG7