Biopharmaceutics Announces FDA Approval and Information and Testing Request.BELLPORT, N.Y.--(BUSINESS WIRE)--March 20, 1995--Biopharmaceutics Inc.(ASE (Adaptive Server Enterprise) A relational DBMS from Sybase that runs on Windows NT/2000, Linux and a variety of Unix platforms. ASE is a comprehensive and robust data management product with a long history dating back to the late 1980s. :BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) announced today that the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved for production and distribution three of the eight validation See validate. validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. products it had submitted in January 1995. In addition, the FDA requested additional information on two of the products and additional testing on three of the products, all of which the company will be providing to the FDA shortly. Edward Fine, president stated, "We are pleased to receive the approval on these three additional products, which we expect to begin shipping before the end of March. We believe that the information requested for two of the other products is very minor in nature and can be provided to the FDA almost immediately, while three of the products will require additional testing, which we expect to provide to the FDA by the first week of April. This is a step toward our return to normalcy nor·mal·cy n. Normality. Noun 1. normalcy - being within certain limits that define the range of normal functioning normality in our relations with the FDA." CONTACT: Biopharmaceutics Inc. Stuart Fine, 516/286-5800 |
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