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The FDA's New Guidance on Data Integrity
The Food and Drug Administration (FDA) recently released a draft guidance for industry, “Data Integrity and Compliance with CGMP” (Current Good Manufacturing Practices). See http://1.usa.gov/25IzpM4. While the draft is not legally binding on industry or the agency, it offers the FDA's current thinking on how drug and biologic manufacturers can comply with current Good Manufacturing Practices, to ensure completeness, consistency, and accuracy of data. In recent years, FDA has taken numerous enforcement actions against companies for data integrity-related violations during GMP inspections. In addition to describing the agency's expectations, the document also offers companies a means to reduce potential product liability exposure.
This article highlights some of the key points in the guidance and attempts to identify the agency's central concerns and recommendations.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.