The FDA and Overseas Drug Approvals

by Mark Senak Eye On FDA Where is the Most Promising Pipeline? For a while now, I've been thinking about the growing number of drugs that are being approved overseas and going on the market overseas, but are not getting approved or are getting...

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[ Otros - Música y Ocio ] : hola alguien que sepa ingles me puede traducir esta cancion ???

porque las traducciones de internet estan mal traducidas Letra de la cancion "Ready, Set, Don't Go" de Billy Ray y Miley Cyrus She's gotta do what she's gotta do And I've gotta like it or not She's got dreams too big for this town And she needs to give 'em a shot Whatever they are Looks like she's all ready to leave Nothing left to pack There ain't no room for me in that car Even if she asked me to tag along God I gotta be strong [Chorus] She's at the startin' line of the rest of her life As ready as she's ever been Got the hunger and the stars in her eyes The prize is hers to win She's waitin' on my blessings before she hits that open road Baby get ready Get set Don't go She says things are fallen into place Feels like they're fallen apart I painted this big ol' smile on my face To hide my broken heart If only she knew This is where I don't say what I want so bad to say This is where I want to but I won't get in the way Of her and her drea

James Boyce and Paul Abrams: An Obama-McCain General Election Agreement: Neutering The 527s

John McCain has promised a "respectful" campaign. He cannot match Barack Obama's fundraising ability and would like both candidates to agree to federal limits.

Without a solution to the inevitable 527 problem, however, Barack Obama should not agree to restrict his general election funds to the federal grant. John McCain cannot control 527 expenditures. [n.b.: for the purposes of this article, any non-Party, non-candidate, controlled election money will be called "527"].

There is a mechanism to make this work. It will test whether McCain is committed to a respectful campaign, as he says, and whether he wants to run the lobbyists and PACs out of the campaign financing system.

The agreement must be in writing. It must be published. It must be tightly written. It must be signed by the campaigns and by the Democratic and Republican Parties. There must be automatic pre-determined sanctions that occur within the relevant timeframe of the campaign itself should the provisions be breached. [n.b.: the nominees each take control of their Parties, and thus can get those Parties to accede to whatever agreement the candidates reach. No excuse that "the Party will not agree"].

But, there is an opportunity for an historic deal on these terms:

1. The candidates agree to take federal funding. Re-directing raised funds to the RNC and DNC is allowed.
2. The candidates and parties agree to take no PAC and no lobbyist money.
3. To neuter the 527s, the candidates make a joint TV, Radio and Print Ad. The TV ad has both McCain and Obama standing beside one another, and they say: "You have just seen an ad attacking the character or patriotism of one of us. Then Barack says of McCain, and McCain says of Barack: "Well, I'm [name], and I want to tell you that [name] is a trustworthy person, who loves this country." Then, they share sentences that say, "We disagree strongly about policies and programs, and how to get America to a better place. We urge you to ignore the ad you just saw. It is not accurate, and does not represent what we think of one another."
4. Those ads are run, on a dollar-for-dollar basis, after either McCain or Obama, notes to the other that a 527, or the RNC/DNC, will be running an attack ad against the other candidate.
5. The costs for running those counter-ads are shared equally by the campaigns and parties.
6. Same concept for radio and direct mail and newspaper ads. One-for-one.

Before everyone piles on, believing that Obama will have relinquished an advantage, consider how this would work. Obama (and McCain) fundraising would go to the Party, not the campaigns. The Party can conduct campaigns in concert with the candidates; that was done in the 2004 campaign.

By agreeing not to take PAC or lobbyist money, we call McCain's bluff and determine whether he is truly opposed to such funding sources.

The joint ad puts the prestige of the other candidate on the side of the attacked. This blunts the impact of the attack. Republicans are far more likely to run vicious attack ads than Democrats. There is no evidence they could have won any Presidential campaign without them.

By requiring a dollar-for-dollar "buy", the Republican 527s will cost the McCain campaign whenever they decide to run such an ad. The existence of the counter-ad will neuter the attack ad, and that alone may deter their use. For example, the SwiftBoat ads spent $37 million. Under this proposal, McCain would pay $18.5 million to counter it, reducing the money he has to use his own campaign. The determination that a 527 attack triggers a counter-ad is made by the attacked party. It requires only that a 527 has sponsored the ad, and the designation by the attacked party that the joint-ad should be run.

Thus, 527s do not get a free-ride, their activities compel expenditures by the campaign they purportedly are trying to help. The campaigns will have a strong incentive to "suggest" that the 527s do not expose them to such costs.

In summary this proposal determines whether McCain truly wants a respectful campaign. In exchange for agreeing to take federal funds for the campaign, the deal erects a forcefield--with the counter-ads and the cost of running them on a dollar-for-dollar basis along with the scurrilous 527 ads---to increase the likelihood that the campaign may indeed be respectful. It also tests McCain's commitment to ridding the system of PAC and lobbyist money.

This is eminently reasonable and fair. If McCain rejects it, it will not only have revealed his true nature, but it will also demonstrate Obama's adherence to his promise to try, in good faith, to work out an agreement with his opponent, should he get the nomination.

If McCain accepts it, the campaign will be about Iraq and our overall foreign policy; the economy and energy; education; and universal health care.

We have no doubt that THAT is a campaign Barack Obama would win in a landslide.

Clinton Superdel Contradicts Campaign: I Didn't Decide Over "Bitter" Remarks

ust when did Montana politico Bill Kennedy decide to endorse Hillary Clinton?

The Clinton campaign has suggested the Yellowstone County commissioner picked Clinton only after he heard Barack Obama's now famous "bitter" comments. But Kennedy told FOX News on Tuesday that he decided on Clinton long before that.

"I had been leaning toward Hillary for months," Kennedy said. "I actually decided to endorse her two weeks ago."