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Your search for “park” returned the following results.
…been promising to resume use of the individual criminal liability doctrine known as the Park Doctrine (also known as the Responsible Corporate Officer Doctrine). If this occurs, it would increase…
…free webinar here. The webinar will feature attorneys with decades of experience in FDA’s application of the Park Doctrine. They will: Share their insights of the doctrine from their government…
…Appeals for the D.C. Circuit. WLF argues that excluding executives convicted of misdemeanor offenses under the strict liability Responsible Corporate Officer Doctrine (“RCO or Park Doctrine”) from participation in federal…
…the so-called “Park Doctrine”, under which corporate executives can be prosecuted and convicted of FDC Act violations even though an executive did not participate in, or even know about, the…
The Council for Entrepreneurial Development will hold a “MedTech” forum on June 6, 2007 in Research Triangle Park, NC to discuss FDA’s regulation of medical devices and device reimbursement under…
…tests the limits of the Park doctrine, also known as the “responsible corporate officer” doctrine. The doctrine’s name originated with United States v. Park, 421 U.S. 658 (1975) (here), in…
…the Tenth Circuit affirmed. For those followers of the Park doctrine, the Tenth Circuit opinion contains a brief, but potentially important discussion of the relevance of Park to CMPs. In…
…derives from the 1975 U.S. Supreme Court case of United States v. Park. FDA believes that the Park doctrine allows the government to obtain a misdemeanor criminal conviction against a…
…that the decision takes the already scary “Park Doctrine” even farther than previously thought possible. The Supreme Court’s Park case, as we have been recently pointing out, imposes strict criminal…
…not a Park prosecution. Thus, we do not know if this ruling will impact the government’s future use of the Park Doctrine. However, the ruling is a severe blow to…
…provision of the FDC Act does not require any such intent. Rather, an individual can be prosecuted under the “Park Doctrine” if that person was in a responsible position of…
…In the FDA-regulated arena, the government has been bolstered by the U.S. Supreme Court precedents set in United States v. Dotterweich, 320 U.S. 277 (1943), and United States v. Park,…
…for the government without a defendant admitting to active participation in the underlying crime. For those blog readers familiar with the Park doctrine (see here) and repeated government statements that…
…who “park” their exclusivity would speed delivery of generic drugs and provide substantial cost savings to American consumers. Page 150 of the Proposed Budget, in a section titled “Major Savings…
…Administration appears to want to address is a first applicant’s ability to “park” 180-day exclusivity eligibility because of alleged “deficiencies” (e.g., unresolved cGMP concerns) that prevent FDA from granting final…