Clinical trials did not have to be very big, and drugs could get approved quickly.
Their recommendation is non-binding, but Arena is unlikely to get approved in the near term without it.
Regulators are threatening to close loopholes that allow some devices to get approved without proof that they work.
Mortgage rates are at historic lows, yet many would be homebuyers cannot get approved to close the deal.
Transmission, especially long high-voltage lines that cross states, is extraordinarily hard to get approved, sited, permitted and paid for.
FORBES: Utility Vs. Utility: Grid Battle Threatens Wind Development
Zipursky said the lawsuit stresses that consumers were harmed financially, so it could get approved as a class action.
The FDA may the final arbiter of the medical products that get approved.
If you pick drugs that are going to get approved that everyone knows are going to get approved, you could lose money.
You can only get approved a visa four days before your departure.
Dealers used to be able to review their allocation of vehicles once a month and request changes that took a week to get approved.
He was told more than once there was no chance for the deal to get approved through a non-SBA route, like a commercial loan.
FORBES: Small Business Funding: Where To Go When The Bank Says No
In order to get approved, Qnexa will probably need a risk evaluation and mitigation strategy (REMS), post-market studies, and warnings in its label, Carr says.
The following video is debate between Forbes senior editor Matt Herper and me over what it will take for more obesity drugs to get approved.
Merck kept insisting that its attempt to get approved its painkiller Arcoxia, designed years ago as a follow-up to the then-successful Vioxx, at least had a chance.
In the two years since we began keeping track of promising experimental drugs, we have seen 13 of them get approved by the U.S. Food and Drug Administration.
On a recent call with patient advocates about muscular dystrophy drugs, Robert Temple, a top FDA official, explained that in some cases surrogates can be enough to get approved.
FORBES: Merck's Big Vytorin Study Could Change Rules For New Cholesterol Drugs
Why is it that a stent or heart valve which requires a big clinical trial to get approved in the U.S. can get approved in Europe with more minimal testing?
The good news is that if Amylin and Eli Lilly can produce data that shows that Bydureon does not push people into this danger zone, the drug should get approved.
Merck (nyse: MRK - news - people ) kept insisting that its attempt to get approved its painkiller Arcoxia, designed years ago as a follow-up to the then-successful Vioxx, at least had a chance.
Store cards have the potential to provide significant benefit irrespective of your chosen course of action because they provide useful rewards, are one of the few credit card genres people with poor or limited credit can get approved for, and have lower fee structures than unsecured credit cards for bad credit.
Thursday, Isis announced trials that could get mipomersen approved in the rare genetic disease familial hypercholesterolemia (FH).
Nor has Abraxis finished the studies required to get Abraxane approved for use in any other cancer.
FORBES: Patrick Soon-Shiong and one of cancer's biggest riddles.
Bell spent 18 months personally negotiating with the FDA to design the studies that would get Soliris approved.
FORBES: How A $440,000 Drug Is Turning Alexion Into Biotech's New Innovation Powerhouse
But before it can forge that path, Sarepta has to get eteplirsen approved.
FORBES: In A First, An Experimental Drug May Help Boys With Muscular Dystrophy
This limited success will probably be enough to get Erbitux approved, given the FDA's new relaxed stance toward cancer drugs.
Soon-Shiong said he would get Abraxane approved via an FDA rule that would let him use just one clinical trial.
FORBES: Patrick Soon-Shiong and one of cancer's biggest riddles.
Product and SEO teams scrambled to implement a fix, get it approved by Google's arbiters and regain the brand's Google status.
ENGADGET: Editorial: FTC and Google -- why the right decision feels so wrong to so many people
Jason Best and Sherwood Neiss helped lead the successful effort to get crowdfunding approved in the JOBS Act passed earlier this year.
应用推荐