alza research 
A DIVISION OF ALZA CORPORATION 
1 December 1976 
Dr. Donald Frederickson 
Director 
National Institutes of Health 
Bethesda, MD 20014 
Dear Dr. Frederickson: 
One purpose of this letter is to put ALZA Research on 
record as subscribing to the NIH guidelines on recombinant DNA 
research, irrespective of the sources of funding for such work. 
I attach an internal memorandum that states our current and 
foreseeable involvement in this area, the former being nil 
and the latter being very substantial. As you probably know 
ALZA has pioneered in bringing membrane technology to bear on 
achieving both continuity and control of drug entry into the 
body through a new class of dosage forms called therapeutic 
systems. I anticipate that significant practical applications 
of molecular biology will depend heavily upon this technology 
and its future extension. 
As the attached memorandum states, you and your colleagues 
have done an admirable job in responding constructively and con- 
fidently to complex and much-debated issues. As an NIH alumnus 
(1961-63), I am pleased to see the institution discharge this 
responsibility so well. 
There is something of a parallel issue in laboratory prac- 
tice that the FDA has recently raised. It relates to adequacy 
of laboratory procedures in work that bears upon laboratory 
testing involved in determining the safety and efficacy of drugs. 
Proposed Good Laboratory Practice Regulations were, as you know, 
published in the November 19 Federal Register. While these are 
nominally directed solely at the pharmaceutical industry, it is 
difficult to see how they will not roll out through the entire 
biomedical research establishment. I am sure you have antici- 
pated being asked whether the intramural research program and 
extramural grantees will be expected to adhere to Good Laboratory 
Practices. I realize that the proposed regulations have been 
written in cognizance of commentary from NIH, NCI, CDC, and other 
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