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This historic book may have numerous typos and missing text. Purchasers can download a free scanned copy of the original book (without typos) from the publisher. Not indexed. Not illustrated. 1990 edition. Excerpt: ...that such drug is safe for use under such conditions" (21 U.S.C. 355(d) 1982). Any doubts about safety are to be resolved by denying...
This historic book may have numerous typos and missing text. Purchasers can download a free scanned copy of the original book (without typos) from the publisher. Not indexed. Not illustrated. 1990 edition. Excerpt: ...that such drug is safe for use under such conditions" (21 U.S.C. 355(d) 1982). Any doubts about safety are to be resolved by denying approval. There has been little public argument that the statutory requirements for proof of safety or that FDA's interpretation and implementation of them have been unduly demanding. Indeed, the most frequent and persistent criticism of FDA's administration of the requirements for proof of safety has been expressed in congressional hearings called to chastise the agency for being insufficiently demanding. Yet FDA's requirements for proof of safety have been a principal and highly controversial obstacle to the introduction of new contraceptive steroids. The controversy over regulatory aspects of the safety of steroidal contraceptives focuses on two sets of issues: risk characterization and assessment and risk management (National Research Council, 1983). The first set of issues relates to the identification and quantification of the risks presented by contraceptive drugs and, in particular, the scientific appropriateness of FDA's requirements for the toxicological screening of such drugs. That set of issues is considered in this section. The second set of issues relates to the judgment of what level of risks in a new contraceptive should, for purposes of FDA approval, be acceptable in light of the benefits provided by the contraceptive. That set of issues is considered later in this chapter. Toxicological Testing of Contraceptive Drugs Since the introduction of the first oral contraceptives in the 1960s, the FDA's requirements for toxicological testing of proposed contraceptive drugs have been much more demanding than its requirements for the testing of other drugs. The rationale for the more severe...
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