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Where to Point the Finger: Omnicare’s Attempt to Rectify the Collective Scienter Debate

Michael T. Jones 0 1 0 This Notes is brought to you for free and open access by the Law Journals at Digital Commons @ Boston College Law School. It has been accepted for inclusion in Boston College Law

Control Strategy for Small Molecule Impurities in Antibody-Drug Conjugates

Antibody-drug conjugates (ADCs) are an emerging class of biopharmaceuticals. As such, there are no specific guidelines addressing impurity limits and qualification requirements. The current ICH guidelines on impurities, Q3A (Impurities in New Drug Substances), Q3B (Impurities in New Drug Products), and Q6B (Specifications: Test Procedures and Acceptance Criteria for...

Avant-garde: The Convulsions of a Concept

: AVANT-GARDE: THE CONVULSIONS OF A CONCEPT MICHAEL T. JONES The Ohio State University I An eerie calm hangs over the concept of the «avant-garde.» At a