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

@dgingery These were guidance documents that, generally, were in very advanced stages of development, and close to being releasing before the lapse in appropriations. It's the case that new guidance development is being affected by the lapse.

RT @fdalawblog: New FDA Guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway Guidance for Industry - https://t.co/PCfFXayaOS

During the lapse in funding, #FDA continues to advance certain policy, consistent with what's permissible under law. Like today’s guidance, supported by carryover user-fees.

As more drugs are being approved under the accelerated approval pathway and we make more robust use of accelerated approval, as a way to advance promising medicines for serious diseases, it’s important to update our regulatory recommendations for how these products are labeled.

The accelerated approval pathway facilitates earlier approval of drugs that treat serious conditions and the clinical community has garnered a greater understanding of how certain surrogate endpoints inform clinical practice.

Appreciate the chance to join thousands of my colleagues from CDER and CBER today to discuss the impacts of the #shutdown on our continuing operations, and the steps we’re taking to continue to fulfill our mission and our mandate to the American people. https://t.co/BmtrDuR687

Today, #FDA finalized a policy on labeling for drugs approved under accelerated approval, reflecting the more frequent use of this pathway for drugs used in certain clinical settings. https://t.co/xtNGW1wkj0

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices https://t.co/sRfZy6UqT3

@dgingery We'll be continuing high-risk inspections of compounding facilities. It will be excepted work, meaning our dedicated inspectors will not be paid for these assignments during the funding lapse, but compounding inspection work continues.

In 2018, #FDA set and broke records for novel drug approvals. ICYMI: #FDAVoices posted earlier this month highlights the innovative regulatory tools used to enhance efficiency and expedite the review and approval of drugs. https://t.co/AhBDbbp23R

New article from @NatRevClinOncol highlights @FDAOncology work in 2018, a year of many drug-related firsts for #FDA and record novel drug approvals. Many will have a significant impact on improving health. https://t.co/3etd8yvohp QT @NatRevClinOncol: )

#FDA is committed to making sure that health care providers have accurate, actionable information about prescription medications, so that patients and providers can make the most informed decisions about a drug’s risks and benefits.

We’re taking new steps to help ensure a product’s labeling provides actionable, complete information about the clinical evidence supporting these accelerated approvals and clearly states the post-market commitments that may have to be met for an indication to remain approved.

RT @endpts: FDA finalizes accelerated approval labeling guidance https://t.co/dulVwEepmE

RT @califf001: This makes me homesick. Just passed my 2 year "cooling off" period. Best wishes to the hard working FDA workforce. The American public depends on you, so keep the faith! https://t.co/qJtZzlVTpg

RT @dgingery: Compounding Inspections continue despite lack of user fee funding... https://t.co/n58IDlryHR

RT @SGottliebFDA: THREAD: We announced two more steps in efforts to modernize FDA’s 510(k) path for medical devices.… https://t.co/Vo3SdVi7W4

RT @RAPSorg: .@US_FDA Finalizes Accelerated Approval Labeling Guidance | #Regulatory Focus https://t.co/VpVzq4zObP #FDA #pharma #biotech

We've advanced a major new modernization of the 510(k) process to enable modern performance standards -- that reflect up-to-date considerations for the safety and utility of medical devices -- to serve as more modern predicates for new 510(k) clearances https://t.co/qLJiQa7dbe

The clinical effects of patient immune responses are highly variable, ranging from no measurable effect to extremely harmful, so detection and analysis of anti-drug antibody formation is an important tool in understanding these potential patient immune responses

@dgingery These were guidance documents that, generally, were in very advanced stages of development, and close to being releasing before the lapse in appropriations. It's the case that new guidance development is being affected by the lapse.

RT @fdalawblog: New FDA Guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway Guidance for Industry - https://t.co/PCfFXayaOS

During the lapse in funding, #FDA continues to advance certain policy, consistent with what's permissible under law. Like today’s guidance, supported by carryover user-fees.

As more drugs are being approved under the accelerated approval pathway and we make more robust use of accelerated approval, as a way to advance promising medicines for serious diseases, it’s important to update our regulatory recommendations for how these products are labeled.

The accelerated approval pathway facilitates earlier approval of drugs that treat serious conditions and the clinical community has garnered a greater understanding of how certain surrogate endpoints inform clinical practice.

Appreciate the chance to join thousands of my colleagues from CDER and CBER today to discuss the impacts of the #shutdown on our continuing operations, and the steps we’re taking to continue to fulfill our mission and our mandate to the American people. https://t.co/BmtrDuR687

Today, #FDA finalized a policy on labeling for drugs approved under accelerated approval, reflecting the more frequent use of this pathway for drugs used in certain clinical settings. https://t.co/xtNGW1wkj0

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices https://t.co/sRfZy6UqT3

@dgingery We'll be continuing high-risk inspections of compounding facilities. It will be excepted work, meaning our dedicated inspectors will not be paid for these assignments during the funding lapse, but compounding inspection work continues.

In 2018, #FDA set and broke records for novel drug approvals. ICYMI: #FDAVoices posted earlier this month highlights the innovative regulatory tools used to enhance efficiency and expedite the review and approval of drugs. https://t.co/AhBDbbp23R

New article from @NatRevClinOncol highlights @FDAOncology work in 2018, a year of many drug-related firsts for #FDA and record novel drug approvals. Many will have a significant impact on improving health. https://t.co/3etd8yvohp QT @NatRevClinOncol: )

#FDA is committed to making sure that health care providers have accurate, actionable information about prescription medications, so that patients and providers can make the most informed decisions about a drug’s risks and benefits.

We’re taking new steps to help ensure a product’s labeling provides actionable, complete information about the clinical evidence supporting these accelerated approvals and clearly states the post-market commitments that may have to be met for an indication to remain approved.

RT @endpts: FDA finalizes accelerated approval labeling guidance https://t.co/dulVwEepmE

RT @califf001: This makes me homesick. Just passed my 2 year "cooling off" period. Best wishes to the hard working FDA workforce. The American public depends on you, so keep the faith! https://t.co/qJtZzlVTpg

RT @dgingery: Compounding Inspections continue despite lack of user fee funding... https://t.co/n58IDlryHR

RT @SGottliebFDA: THREAD: We announced two more steps in efforts to modernize FDA’s 510(k) path for medical devices.… https://t.co/Vo3SdVi7W4

RT @RAPSorg: .@US_FDA Finalizes Accelerated Approval Labeling Guidance | #Regulatory Focus https://t.co/VpVzq4zObP #FDA #pharma #biotech

We've advanced a major new modernization of the 510(k) process to enable modern performance standards -- that reflect up-to-date considerations for the safety and utility of medical devices -- to serve as more modern predicates for new 510(k) clearances https://t.co/qLJiQa7dbe

The clinical effects of patient immune responses are highly variable, ranging from no measurable effect to extremely harmful, so detection and analysis of anti-drug antibody formation is an important tool in understanding these potential patient immune responses