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The Round Table
First FDA regulation casualty I've heard of
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<blockquote data-quote="idbowman" data-source="post: 461264" data-attributes="member: 2165"><p>Aug 8th is when things go into effect on paper, but everyone has two full years to comply with the new regulations. That means we've got about 26 months before the post-2007s are either approved or off the market. A lot can happen in two years.</p><p></p><p>I'd bet dollars to to donuts that the reason we haven't heard of any action yet is because no one <em>can</em> take action yet, as the regulations aren't in force, yet. The earliest we could possibly expect to see the industry pursue legal action/relief is on the August effective date, but I'd imagine it will be a few months after that before anything starts to move.</p><p></p><p>In short: The relevance of August 8 is nothing more than that's the earliest companies can begin submitting products for approval and/or begin pursuing legal means to challenge the regulations/process. </p><p></p><p></p><p>I should add: I'm no lawyer. I work with contracts and legalese all day, every day, so I have a reasonable understanding of the situation, but that doesn't make me anything close to an expert. I have a few lawyer friends who agree with my interpretation, but none of us have read the 500 pages in their entirely, so take this all with a grain of salt.</p></blockquote><p></p>
[QUOTE="idbowman, post: 461264, member: 2165"] Aug 8th is when things go into effect on paper, but everyone has two full years to comply with the new regulations. That means we've got about 26 months before the post-2007s are either approved or off the market. A lot can happen in two years. I'd bet dollars to to donuts that the reason we haven't heard of any action yet is because no one [i]can[/i] take action yet, as the regulations aren't in force, yet. The earliest we could possibly expect to see the industry pursue legal action/relief is on the August effective date, but I'd imagine it will be a few months after that before anything starts to move. In short: The relevance of August 8 is nothing more than that's the earliest companies can begin submitting products for approval and/or begin pursuing legal means to challenge the regulations/process. I should add: I'm no lawyer. I work with contracts and legalese all day, every day, so I have a reasonable understanding of the situation, but that doesn't make me anything close to an expert. I have a few lawyer friends who agree with my interpretation, but none of us have read the 500 pages in their entirely, so take this all with a grain of salt. [/QUOTE]
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First FDA regulation casualty I've heard of
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