The fact of the matter is that the pre-approval testing of drugs in the 1980s was far less vigorous than what now happens.
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Merck is setting a good example by evaluating the drug in steps, carefully assessing its effect on patients, and not proceeding toward approval before testing the effect of the drug on patient outcomes in a large study.
The idea is to avoid cumbersome double-testing and approval procedures by both sides.
Back then, a new drug to treat the pain of arthritis would only need to complete 90 days of continuous testing before approval.
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Give pillmakers the option of sending a new drug to a nongovernment testing lab for approval.
For one thing, it signals that these companies are finding ways of using these new technologies to make their medicines more effective --making for better odds in getting Food and Drug Administration approval and reducing money wasted testing drugs that won't work in human beings.
The typical drug takes five years or more of clinical testing to win regulatory approval.
Initially the brainchild of Alain Carpentier, a surgeon at Paris' Georges Pompidou Hospital, the device is awaiting approval from French authorities for human testing.
The FDA unexpectedly told the companies in November 2007 that they needed to do further testing, holding up the approval process.
The FDA approval for Bydureon requires Amylin to conduct additional testing to further assess the drug's impact on thyroid cancer and cardiovascular disease.
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In order to reach as many customers as possible, RIM has garnered the support of as many as 150 carriers across the world that are testing out the BB10 devices in their labs for approval.
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Carmat will begin testing about 20 of these bio-prosthetic hearts when it gets approval, and the process is expected to take about two years.
Based on a thorough review of data submitted by Lilly that was obtained from pre-clinical testing in animals and clinical trials in thousands of diabetics, FDA granted marketing approval for human insulin in October 1982.
Regulations that the government alleges Wilson violated would require approval for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of firearms including blueprints, drawings and plans, or just about every aspect required to print a gun using a 3-D printer.
Zadaxin should have won U.S. approval by now, but early trials by a previous licensee were poorly designed, forcing SciClone to extend testing.
It says partial approvals like the one for StarLink should be discontinued and that a procedure for testing for the presence of unapproved DNA should be a pre-condition for a crop's approval.
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Drugs named in the deal include Breo Ellipta, a once-a-day inhaled treatment that just received approval from the U.S. Food and Drug Administration, and two treatments that have entered late-stage testing.
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