Authorized generics

During the 180-day exclusivity period, the presence of an authorized generic as a second generic entrant works to intensify price competition. However, an interesting policy issue is whether there are situations where an authorized generic from the branded manufacturer adversely affects the total number of generic competitors in equilibrium. (Reiffen and Ward 2006). This is an issue currently under consideration at the U.S. Federal Trade Commission. 

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

A fresh start has been made by Samuel Allen and Edwin Thomas of MIT, with The Structure of Materials (1998), the first of a new MIT series on materials. The authors say that our text looks at one aspect of our field, the structure of materials, and attempts to define and present it in a generic, materials catholic way. They have succeeded, better than others, in integrating some crucial ideas concerning polymers into mainline materials science. 

The use of component logic models to build system fault logic has been discussed by several authors for chemical and electrical systems (Powers and Thompkins, 1974 Fussell, 197.S and Powers and Lapp, 1976). In addition, generic sabotage fault trees have been used for some time in the analysis of security concerns for nuclear power plants (NUREG /CR-0809, NUREG/CR. 121,... 

The review of the data portion of the Indian Point 2 (IP2) and 3 (IPS) PRA (a 1982 internal document prepared by Consolidated Edison and the New York Power Authority) is confined to the plant-specific and generic component failure and service hour data sections because these were the only segments available to the reviewers. The LERs produced during a ten-year span of IP2 s operation were evaluated to determine their applicability to the PRA data needs. It was eventually decided to use only the LERs generated after IP2 became critical (from May 23, 1973 to December 31, 1979) for the component data base development, based on the availability of failure event information and more uniform operability, testing, and reporting criteria. 

Now, for this second edition, an attempt was made to list the top prescription drugs in the U.S. as of 1985-some ten years later than the earlier tabulation. This new listing was done by the author based on his interpretation of the sales list by trade name in the magazine/1/ne/-/car) Druggist for February 1986 it gives approximate rank by generic product as of the date of manuscript preparation in 1986. See Table 2. 

There are several significant permit conditions. As with all other OCS permits, the discharge of oil-based muds is prohibited. Similarly, the permit does not unconditionally authorize the discharge of any of the eight generic muds. Their discharge is subject to limitations on additives. To monitor the use of mud additives, the permit requires the additive not to drop or to decrease the 96-hr median lethal concentration (LC ) test below 7,400 ppm on the basis of the suspended particulate phase or 740 ppm for the whole mud. This parameter is based on a test of Generic Mud 8, which is formulated with 5% mineral oil. 

We should not minimize the effects that electronic searching of patents has had on the business of research. In 1990, CAS introduced MARPAT, which is a database of Markush (generic) structures found in patent documents [1]. This database provided a valuable tool for patent searching in a more comprehensive way than had been available previously. In 1995, CAS launched SciFinder, which provided access to the patent literature for chemists on their desktops. Using the SciFinder interface, one may search for research topics, authors, companies, or structures/reactions. From a practical viewpoint, SciFinder did more to enhance the searching capabilities of the medicinal chemist than any other tool. Even today, SciFinder continues to provide a first pass through the patent literature when chemists want to include patents in their searching. Indeed, when a search is performed, patent references are included in the answer set. Only very recently have there been additional tools to search the patent literature that have found widespread use. 

The present author [1,2] has proposed that it is useful to distinguish between development and generic bioequivalence. 

The author of the FDA memo revealing the decision to hide the existence of the clinical trials that had failed to find a difference between drug and placebo was Dr Paul Leber, Director of the FDA Division of Neuropharmacological Drug Products. Here is what he wrote about the labelling of Cipramil, which is referred to by its generic name, citalopram, in the document ... 

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