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Latest From Endo International plc
COVID-19 Vaccines: US Distribution Plans Include ‘Data Lake’ For Centralized Tracking
Most vaccines will be distributed centrally by McKesson, but those with ultra-cold storage requirements will be shipped directly from the manufacturer to the vaccination site. Data exchange system will enable public and private databases to talk to each other and help ensure individuals receive timely revaccination with a second dose of the same vaccine regardless of location.
A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
OxyContin Reformulation Reduced Abuse Via Non-Oral Routes But Not Overall Abuse, US FDA Finds
FDA says it is unclear whether Purdue’s OxyContin abuse deterrent reformulation reduced opioid overdoses or had a net public health benefit. Briefing document for upcoming advisory committee meeting asks panel to discuss Purdue’s four postmarket studies but does not include voting question on possible change in labeling claims.
CDC Bets Vaccine Stability Conditions Will Change, Urges Against Freezer Purchases
Even as Pfizer and Moderna says their vaccines would need to be stored at very low temperatures, CDC official urges delay on equipment acquisition.
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- Anchen Pharmaceuticals, Inc.
- ASTORA Women's Health
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- Endo Pharmaceuticals Holdings Inc.
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