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

RT @US_FDA: Have you checked your fridge and freezer? Consumers should discard listed pre-cut melon products potentially implic… https://t.co/VLa4IpXpNA

RT @US_FDA: FDA will hold a public meeting on July 12 on the opportunities & challenges of the use of animal cell culture techn… https://t.co/3LCL3dxWta

RT @FDAfood: We continue to update the list of distributors.... https://t.co/nEiO6sNI0G QT @FDAfood: RECALL UPDATE: Expanded list of stores who may have sold recalled pre-cut melon. Check refrigerator & freezer esp… https://t.co/F4waBAYub9)

RT @TheLancet: New #lancethaemcommission highlights dramatically increasing survival rates for #bloodcancers – including #lymphoma… https://t.co/eeDFI2Phcj

#FDA worked w/Del Monte to recall 6 & 12oz trays of broccoli, cauliflower, carrots, dill dip sold by retailers in IA, MN, WI; also recalling 28oz trays in IL, IN due to 78 reported Cyclospora illnesses. Consumers should discard these products immediat

#FDA OUTBREAK UPDATE: An outbreak of 73 Salmonella infections from 31 states has been linked to Kellogg’s Honey Smacks cereal. Do not eat this cereal. Throw it away or return it to the place of purchase https://t.co/FOL12mRvZh https://t.co/knc557zDX1

RT @TheLancetHaem: Changes in treatment paradigms for #haematological malignancies should spur changes in existing systems of… https://t.co/PQ3ZKFPZ9H

#FDA actively investigating 78 reported Cyclospora illnesses associated with Del Monte vegetable trays in IA, IL, IN, MN, WI; currently reviewing distribution, supplier information and will provide updates as available. For more info on the recalled items

A new #FDA Series! Sunday TWEETORIALS! This one an overview of #FDA’s expedited development and review pathways, and their public health purpose: FDA operates several programs to speed development of drugs, e.g. for serious or life-threatening illness lac

Check your fridge and freezer for Del Monte 6 and 12oz vegetable trays withdrawn from the market on 6/8 in IA, MN, WI; however, consumers may still have product in their homes. 28oz vegetable trays also being recalled in IL, IN and should be discarded htt

“Priority Review” establishes a 6-mo review for drugs which may demonstrate a substantive improvement over available therapy. While shorter, these reviews are still exhaustive. If important Qs can’t be fully resolved, FDA can continue past the goal date h

Some of these approaches can help make development more efficient, in addition to the shorter review times. Pinnow recently published a comprehensive analysis over 14-year period that found no relationship between review times and subsequent safety change

“Fast Track” confers special FDA attention and rolling reviews on drugs targeting serious unmet needs, allowing applicant to submit parts of application before complete submission is ready. This does not otherwise influence standard of approval in any way

While AA may result in more uncertainty about impact on long term outcomes, including efficacy, that's largely the acknowledged tradeoff. People with lives at stake want and need new treatments and are willing to accept more uncertainty on clinical outcom

These pathways are often misunderstood. The head of #FDA's drug center, Dr. Janet Woodcock, recently published an article in the journal Clinical Trials that addresses myths and realities of these programs https://t.co/L1V19r5gap https://t.co/O8IqTWP2lQ

If in later studies, drugs with Breakthrough designated do not uphold major promise for the therapeutic area, then the Breakthrough designation can (and has been) withdrawn. Gathering real world data outcomes data is also critical

BT is often used in the context of targeted therapies and precision medicine; with drugs tested in small populations enriched for those likely to respond. The no. of approved BT-designated drugs has increased, because more drugs are demonstrating dramatic

Many game changing Breakthrough approvals have been based on outcomes from non-randomized trials that would never have occurred spontaneously and many BT drugs now standard of care for those serious diseases https://t.co/7J11hgWnXx https://t.co/V0Cr0zXx6h

#FDA’s drug approval decisions are based firmly on a judgement that identified benefits will exceed possible risks in an intended population. The revolution in biomedical science can't be ignored. Our expedited pathways help deliver on this promise of new

“Breakthrough Therapy” designation is granted for drugs that've shown an impact on clinical outcomes that would be game changing for people with disease if verified. BT designation, like the others, doesn't change the FDA standard but allows rolling revie

RT @US_FDA: Have you checked your fridge and freezer? Consumers should discard listed pre-cut melon products potentially implic… https://t.co/VLa4IpXpNA

RT @US_FDA: FDA will hold a public meeting on July 12 on the opportunities & challenges of the use of animal cell culture techn… https://t.co/3LCL3dxWta

RT @FDAfood: We continue to update the list of distributors.... https://t.co/nEiO6sNI0G QT @FDAfood: RECALL UPDATE: Expanded list of stores who may have sold recalled pre-cut melon. Check refrigerator & freezer esp… https://t.co/F4waBAYub9)

RT @TheLancet: New #lancethaemcommission highlights dramatically increasing survival rates for #bloodcancers – including #lymphoma… https://t.co/eeDFI2Phcj

#FDA worked w/Del Monte to recall 6 & 12oz trays of broccoli, cauliflower, carrots, dill dip sold by retailers in IA, MN, WI; also recalling 28oz trays in IL, IN due to 78 reported Cyclospora illnesses. Consumers should discard these products immediat

#FDA OUTBREAK UPDATE: An outbreak of 73 Salmonella infections from 31 states has been linked to Kellogg’s Honey Smacks cereal. Do not eat this cereal. Throw it away or return it to the place of purchase https://t.co/FOL12mRvZh https://t.co/knc557zDX1

RT @TheLancetHaem: Changes in treatment paradigms for #haematological malignancies should spur changes in existing systems of… https://t.co/PQ3ZKFPZ9H

#FDA actively investigating 78 reported Cyclospora illnesses associated with Del Monte vegetable trays in IA, IL, IN, MN, WI; currently reviewing distribution, supplier information and will provide updates as available. For more info on the recalled items

A new #FDA Series! Sunday TWEETORIALS! This one an overview of #FDA’s expedited development and review pathways, and their public health purpose: FDA operates several programs to speed development of drugs, e.g. for serious or life-threatening illness lac

Check your fridge and freezer for Del Monte 6 and 12oz vegetable trays withdrawn from the market on 6/8 in IA, MN, WI; however, consumers may still have product in their homes. 28oz vegetable trays also being recalled in IL, IN and should be discarded htt

“Priority Review” establishes a 6-mo review for drugs which may demonstrate a substantive improvement over available therapy. While shorter, these reviews are still exhaustive. If important Qs can’t be fully resolved, FDA can continue past the goal date h

Some of these approaches can help make development more efficient, in addition to the shorter review times. Pinnow recently published a comprehensive analysis over 14-year period that found no relationship between review times and subsequent safety change

“Fast Track” confers special FDA attention and rolling reviews on drugs targeting serious unmet needs, allowing applicant to submit parts of application before complete submission is ready. This does not otherwise influence standard of approval in any way

While AA may result in more uncertainty about impact on long term outcomes, including efficacy, that's largely the acknowledged tradeoff. People with lives at stake want and need new treatments and are willing to accept more uncertainty on clinical outcom

These pathways are often misunderstood. The head of #FDA's drug center, Dr. Janet Woodcock, recently published an article in the journal Clinical Trials that addresses myths and realities of these programs https://t.co/L1V19r5gap https://t.co/O8IqTWP2lQ

If in later studies, drugs with Breakthrough designated do not uphold major promise for the therapeutic area, then the Breakthrough designation can (and has been) withdrawn. Gathering real world data outcomes data is also critical

BT is often used in the context of targeted therapies and precision medicine; with drugs tested in small populations enriched for those likely to respond. The no. of approved BT-designated drugs has increased, because more drugs are demonstrating dramatic

Many game changing Breakthrough approvals have been based on outcomes from non-randomized trials that would never have occurred spontaneously and many BT drugs now standard of care for those serious diseases https://t.co/7J11hgWnXx https://t.co/V0Cr0zXx6h

#FDA’s drug approval decisions are based firmly on a judgement that identified benefits will exceed possible risks in an intended population. The revolution in biomedical science can't be ignored. Our expedited pathways help deliver on this promise of new

“Breakthrough Therapy” designation is granted for drugs that've shown an impact on clinical outcomes that would be game changing for people with disease if verified. BT designation, like the others, doesn't change the FDA standard but allows rolling revie