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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

ISO 10651-5:2006, Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

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Prescription Drugs: From Costs and Bad Reputation to Civica Rx and Amazon to the Rescue

Health Populi

Over the ten years 2006 to 2016, deductibles increased an average of 176% and coinsurance, 67%. Wage growth over that decade was relatively flat, as workers covered by insurance through employers traded off health benefits for wage increases. They’ll begin to apply to the FDA in early 2019 to make and sell the generic drugs.

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Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

Drug & Device Law

If the antivaxxers win in DeCostanzo , then society as a whole loses, because as the Supreme Court stated in Bruesewitz , “the elimination of communicable diseases through vaccination” is “one of the greatest achievements of public health in the 20th century.” 2006 WL 2038436, at *8 (N.D.N.Y. 2022 WL 17338047, at *1.

FDA 115
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Supreme Court Halts OSHA Mandatory Large Employer Vaccination Mandate

Drug & Device Law

The Act empowers the Secretary to set workplace safety standards, not broad public health measures.”). OSHA draws a distinction between “hazards that employees face at work” and “broad public health measures.” for an emergency temporary standard. . . 655(c)(1). for an emergency temporary standard. . . 120, 159 (2000).

COVID-19 105