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The FDA came out with its first set of regulations in 1970 and a revised version in 1985 Among other things, it recommended a more organized method of testing, by comparing sets of patients on different, predetermined dosage levels against control groups on a placebo The method is known by a variety of terms double-blind, randomized, placebocontrolled, and dose-response The FDA had the clout to do this, of course, because it could declare that this type of trial was necessary to prove a drug s efficacy The new approach also meant the FDA had to beef up its own staff by hiring experts such as statisticians As Richard Cooper, the agency s chief counsel from 1977 to 1979, put it: Under the 1962 law, the FDA demanded a new level of scientific rigor in studies submitted to show the effectiveness of new drugs The FDA pushed the envelope.



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n market neutral equity investing, the investor buys winners securities that are expected to do well over the investment horizon and sells short losers securities that are expected to perform poorly. Unlike traditional equity investing, market neutral investing takes full advantage of the investor s insights: whereas the traditional investor would act and potentially bene t only from insights about winning securities, the market neutral investor can act on and potentially bene t from insights about winners and losers. To achieve market neutrality, the investor holds approximately equal dollar amounts of long and short positions. Furthermore, the securities are selected with careful attention to their systematic risks. The long positions price sensitivities to broad market movements should virtually offset the short positions sensitivities, leaving the overall portfolio with negligible systematic risk. This means that the portfolio s value does not rise or fall just because the broad market rises or falls. The portfolio may thus be said to have a beta of zero. This does not mean that the portfolio is risk-free. It will retain the risks associated with the selection of the stocks held long and sold short. The value-added provided by insightful security selection, however, should more than compensate for the risk incurred.





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(The main exceptions to the rigorous trial demands are generic drugs, which are low-cost copies of name brands In this case, the idea is that the generics should be able to get approval based on the original drugs clinical trials, because they are virtually identical to those drugs; to require their own trials would be like asking the first drugs to redo their whole submission And if generic manufacturers did not have to spend tens of millions of dollars repeating the patient trials, they could charge far lower prices In 1984, that principal was enshrined in the Drug Price Competition and Patent Term Restoration Act usually known as the Hatch-Waxman Act in honor of its prime sponsors, Republican Senator Orrin Hatch of Utah and Democratic Congressman Henry Waxman of California) As usual, tragedies extended the FDA s power An estimated 200,000 women suffered miscarriages, pelvic inflammatory disease, and unplanned.

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