For the class 1 studies it does. You try to have some longitude

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Mar 28, 2020
11:54:36am

Archaea Intervention Needed

For the class 1 studies it does. You try to have some longitude

In your study.

You can use intermediate endpoints.

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Archaea

Bio page: Archaea
Joined: Mar 28, 2001
Last login: Jun 17, 2024
Total posts: 95,472 (3,159 FO)

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Messages

Author

Time

The FDA should get out of the way and let the states do testing/experiments.

a priori

3/28/20 10:35am

Safety and Effectiveness. There is a reason we enacted the FDCA, starting in

Archaea

3/28/20 10:36am

Think about how different technology and communication was back then...also,

a priori

3/28/20 10:40am

We have such asymmetry of information, leaving the field unregulated is a

Archaea

3/28/20 10:42am

It won't be unregulated.

a priori

3/28/20 10:42am

State regulators don't have the expertise. The FDA has more than 15,000

Archaea

3/28/20 10:44am

Markets in everything. People would move for the right price.

a priori

3/28/20 10:45am

Is that the same FDA who approved the early kits that were faulty?

HighHorse

3/28/20 10:47am

It was the CDC who oversaw production

Everyman

3/28/20 10:50am

Yes, but the FDA did halt other test kits from being used.

HighHorse

3/28/20 10:55am

No bureaucracy works well in exigent circumstances. Bureaucracies

Archaea

3/28/20 11:00am

You and I differ on that. I trust states more than the bureaucratic mess that is DC.

HighHorse

3/28/20 11:01am

Have you worked with the FDA? In order to be effective

Archaea

3/28/20 11:05am

No I haven't thank goodness. My problem with the FDA

HighHorse

3/28/20 11:41am

I am generally negative about gov't agencies but not this one.

Archaea

3/28/20 11:42am

So the best organization in the world makes mistakes, how many more would

Archaea

3/28/20 10:59am

You ought to read up on how well it's performed that task.

Mises

3/28/20 11:22am

Some of it is the process drug companies use, Reverse Payments

Archaea

3/28/20 11:26am

Yep Remember all those drug recalls after getting FDA approval?

Mises

3/28/20 11:35am

There are several processes in place. First, the FDA can recall and, second

Archaea

3/28/20 11:42am

No, but they should fast track approval somehow

I'mBatman

3/28/20 11:51am

For the class 1 studies it does. You try to have some longitude

Archaea

3/28/20 11:54am

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