Solely in the case of drug products for which the analytical methods described in subparagraphs (A) and (B) cannot be applied, because such drug products have been demonstrated not to rely primarily on systemic absorption to achieve their effectiveness, bioavailability and bioequivalence may be based on other types of evidence, as prescribed by regulation promulgated by the Secretary.

BIO's Primary Concerns on Redraft of S. 812

Sec. 8 - Bioequivalence


PhRMA opposes the drug patents reform bill passed by the Senate Health Committee today, July 11, and charges that the bill is too complex for the senators to comprehend. PhRMA-Edwards/Kennedy PhRMA Statement









The 18-member panel releases its far-from-unanimous decision in favor of a four-year moratorium on therapeutic cloning by a vote of 10 to seven with one member abstaining. Some members voting for the moratorium felt this would allow some time to present their case against human cloning in a more "democratic way." The council also calls for a reproductive cloning ban.


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