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The effect of the new F.D.A. regulations on the drug industry
Author(s) -
Beyer Karl H.
Publication year - 1964
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1964511
Subject(s) - clearance , food and drug administration , pharmaceutical industry , helpfulness , collation , drug , medical prescription , business , medicine , risk analysis (engineering) , marketing , pharmacology , computer science , psychology , social psychology , urology , operating system
Since the proposed regulations regarding clinical investigation of new drugs were published in the Federal Register, the pharmaceutical industry, the clinical investigator, the Food and Drug Administration itself have been plunged into a tremendously disruptive and costly activity. The Food and Drug Administration may not have realized all the problems that the new regulatioru have created. However, without their gUidance on policy and a mutual sense of trust and helpfulness, the industry cannot effectively approach some of the problems relating to the delineation of authority and responsibility of clinical investigators, the role of clinical pharmacologists in the initial assessment of new drugs, the basis for assessment of utility of numerous prescription drugs cleared by the F.D.A. on the basis of safety prior to Oct. 10, 1962, and the reporting and collation of adverse reactioru. Wisely and efficiently administered, the new regulations can go a long way toward raising the standards of drug research, but it is clear that the pharmaceutical companies will be called on for still greater total research capability and expenditures if we are to maintain, in this new environment, the tremendous strides that have been made in the advancements of therapy in our generation.