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PHARMAKINETICS LABORATORIES REPORTS RECEIPT OF WARNING LETTER FROM FDA

 BALTIMORE, Dec. 30 /PRNewswire/ -- PharmaKinetics Laboratories, Inc. (OTC Bulletin Board: PKLB), today reported the receipt of a warning letter from the Food and Drug Administration (FDA) on Dec. 28, 1993. The letter stated that the company has violated certain FDA regulations in failing to follow its own protocols with respect to test subject inclusion and exclusion criteria, failing to document the medical basis for the discretionary inclusion of subjects who did not meet the inclusion criteria and failing to inform its Institutional Review Board of protocol changes during studies conducted in 1990 and 1991.
 The FDA has advised the company to take corrective action and has advised that failure to do so could result in further regulatory action. The company is confident its ongoing corrective action will resolve the deficiencies and is working with the FDA to ensure resolution of all outstanding issues at the earliest possible date.
 PharmaKinetics Laboratories, Inc., is a leading drug development company providing services to pharmaceutical firms seeking new drug approvals in the United States and Canada.
 -0- 12/30/93
 /CONTACT: V. Brewster Jones, president and chief executive officer of PharmaKinetics Laboratories, 410-385-4500/
 (PKLB)


CO: PharmaKinetics Laboratories, Inc.; Food and Drug Administration ST: Maryland IN: MTC SU:

DT-DC -- DC006 -- 8048 12/30/93 12:06 EST
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Publication:PR Newswire
Date:Dec 30, 1993
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