Politwoops
Explore the Tweets They Didn't Want You to See
Politwoops tracks deleted tweets by public officials, including people currently in office and candidates for office.
Politwoops tracks deleted tweets by public officials, including people currently in office and candidates for office. If you think we're missing someone, please email us with their name, state, political party, office they hold or are seeking and, of course, their Twitter handle.
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SteveFDA (R-D.C.)
@SGottliebFDA
FDA continues to learn of cases of patient illnesses & death due to improperly compounded drugs. In 2017, at least 43 patients developed vision loss after injection in the eyeball with a compounded combination of a steroid and and anti-infective drug during cataract surgery. https://t.co/akwARlqCxQ
SteveFDA (R-D.C.)
@SGottliebFDA
We pursue a risk-based & for-cause approach to inspections and enforcement, focusing on sterile compounding. Since 2013, there have been 201 for-cause inspections (adverse events, product quality, facility concern), 272 surveillance inspections and 188 follow-up inspections. https://t.co/beFLKtRfLX
SteveFDA (R-D.C.)
@SGottliebFDA
Sterile compounding requires a controlled environment with filtered air, controlled pressure, particle monitors, special equipment & protective clothing. We continue to observe sterile compounding outside controlled environments & in egregious conditions w/ mold growth & vermin. https://t.co/MH9KP1oP6U
SteveFDA (R-D.C.)
@SGottliebFDA
The vast majority of compounding inspections since Oct. 2012 have led to voluntary recalls (220) or regulatory actions (227 warning letters). FDA has also pursued civil injunctions and criminal actions. https://t.co/3s8NNpXuSg https://t.co/GJjFukU9DC
SteveFDA (R-D.C.)
@SGottliebFDA
To fully realize the DQSA framework, we have also issued 22 draft and revised draft guidance documents and finalized 15. We have also issued 3 rules – finalizing one – and issued a revised draft Memorandum of Understanding with the states. https://t.co/A9oXEAvWg8
SteveFDA (R-D.C.)
@SGottliebFDA
Our Drug Compounding Policy Plan for 2018 https://t.co/ekG4R4Hvh8 lays out how we address quality standards for outsourcing facilities, regulate compounding from bulk drug substances, and restrict compounding of drugs that are essentially copies of FDA-approved drugs.
SteveFDA (R-D.C.)
@SGottliebFDA
Two revised draft guidances are coming soon - one relates to insanitary conditions at compounding facilities and a second relates to current good manufacturing practice (CGMP) requirements tailored to the operations of outsourcing facilities.
SteveFDA (R-D.C.)
@SGottliebFDA
Two revised draft guidances are coming soon - one relates to insanitary conditions at compounding facilities and a second relates to current good manufacturing practice (CGMP) requirements tailored to the operations of outsourcing facilities. https://t.co/rQHPQNFLCQ
SteveFDA (R-D.C.)
@SGottliebFDA
One 2018 goal is solidifying our partnership with state regulatory authorities who license and set standards for compounding pharmacies and investigate and respond to complaints about them and their compounded drugs. I look forward to our annual 50-state meeting in late Sept.
SteveFDA (R-D.C.)
@SGottliebFDA
The revised draft MOU https://t.co/F2Fa9dRR7z would have states ID & report info to FDA on compounders that distribute compounded drugs out of state in inordinate amounts > 50% of total prescription orders. This info will assist FDA in developing risk-based oversight priorities. https://t.co/eutBhdJlh3
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