amercer said:

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I work with a lot of QA people. I assure you every page will get read.

That doesn't guarantee that nothing will go wrong, but they will do their job.

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Greenlander said:

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Do regulatory people in the UK read faster than our people? They've already approved it.

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Quote:

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The two countries vet vaccines differently.

Rather than accepting the findings of vaccine makers, U.S. regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, called the United States an outlier when it comes to the rigor of its vaccine reviews, saying on Tuesday that the FDA "is one of the few regulatory agencies in the world that actually looks at the raw data."

Regulators in Britain and elsewhere in Europe lean more heavily on companies' own analyses. Instead of sifting through raw trial data and crunching the numbers themselves, regulatory agencies often will study a drugmaker's reports and, unless there are anomalies, ground their decisions in company-provided documents.

Still, scientists and industry experts said the British regulators maintained high standards, often acting as a bellwether for other countries' rulings. The regulators themselves said on Wednesday that experts had "unprecedented access" to raw trial data; tested vaccines for quality, batch by batch; and read more than 1,000 pages of documentation.

American and British regulators also have different ways of soliciting outside views.
The FDA consults an independent panel of experts before it decides. In the case of Pfizer's vaccine, that panel will meet on Dec. 10. British regulators seek opinions from a specialist committee, too, but that group has the flexibility to review data and meet as it needs to, allowing it to move more quickly. In all, the committee met for more than 40 hours about the Pfizer vaccine, its chair said on Wednesday.

Like American regulators, their British counterparts have been reviewing vaccine data as it arrived. And different teams worked in parallel, rather than waiting for other parts of the review to finish.

"If you're climbing a mountain, you prepare and prepare," Dr. June Raine, the chief executive of Britain's Medicines and Healthcare Products Regulatory Agency, said on Wednesday. "We started that in June."
When early results arrived on Nov. 10, she said, "We were at base camp." And later, she said, "When we got the final analysis, we were ready for that last sprint."

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AgsMyDude said:

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Greenlander said:

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Do regulatory people in the UK read faster than our people? They've already approved it.

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https://www.chicagotribune.com/coronavirus/ct-nw-nyt-pfizer-covid-vaccine-20201202-chfqzeawtbcbhlgmxydx2uz4ma-story.html

Quote:

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The two countries vet vaccines differently.

Rather than accepting the findings of vaccine makers, U.S. regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, called the United States an outlier when it comes to the rigor of its vaccine reviews, saying on Tuesday that the FDA "is one of the few regulatory agencies in the world that actually looks at the raw data."

Regulators in Britain and elsewhere in Europe lean more heavily on companies' own analyses. Instead of sifting through raw trial data and crunching the numbers themselves, regulatory agencies often will study a drugmaker's reports and, unless there are anomalies, ground their decisions in company-provided documents.

Still, scientists and industry experts said the British regulators maintained high standards, often acting as a bellwether for other countries' rulings. The regulators themselves said on Wednesday that experts had "unprecedented access" to raw trial data; tested vaccines for quality, batch by batch; and read more than 1,000 pages of documentation.

American and British regulators also have different ways of soliciting outside views.
The FDA consults an independent panel of experts before it decides. In the case of Pfizer's vaccine, that panel will meet on Dec. 10. British regulators seek opinions from a specialist committee, too, but that group has the flexibility to review data and meet as it needs to, allowing it to move more quickly. In all, the committee met for more than 40 hours about the Pfizer vaccine, its chair said on Wednesday.

Like American regulators, their British counterparts have been reviewing vaccine data as it arrived. And different teams worked in parallel, rather than waiting for other parts of the review to finish.

"If you're climbing a mountain, you prepare and prepare," Dr. June Raine, the chief executive of Britain's Medicines and Healthcare Products Regulatory Agency, said on Wednesday. "We started that in June."
When early results arrived on Nov. 10, she said, "We were at base camp." And later, she said, "When we got the final analysis, we were ready for that last sprint."

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