FDA is aggressively enforcing GMP compliance; the agency has heightened the sanctions for deviations from good manufacturing practices
Article Abstract:
The Food and Drug Administration (FDA) has made it a priority to require good manufacturing practices (GMPs) of the pharmaceutical industry. Drug GMPs have been required by the FDA for decades, but the generic scandal of the late 1980s caused their profile to increase. Congress responded to this scandal with hearings and a new law, while the FDA retrained its field force, stressing fraud and cover-up issues. The agency also expanded its investigations into the prescription drug and medical device areas, finding equally distrubing GMP variations. Many other federal agencies have responded to budget cuts by focusing on the manufacturing area.
Publication Name: The National Law Journal
Subject: Law
ISSN: 0162-7325
Year: 1999
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Lawyer of the year; David Boies humbled Microsoft, nailed a worldwide vitamin cartel and more
Article Abstract:
David Boies was responsible for the federal government's win in the 1999 antitrust trial of the Microsoft Corp, and the National Law Journal's naming of Boies as 1999's lawyer of the year is discussed. Barry C Scheck and Peter Neufeld of Northwestern University School of Law's Innocence Project and the lawyers working for the conservative Center for Individual Rights were the runners-up.
Publication Name: The National Law Journal
Subject: Law
ISSN: 0162-7325
Year: 1999
User Contributions:
Comment about this article or add new information about this topic:
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