All Food and Drug Administration articles
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News BriefDOJ: Former Magellan quality control director, execs misled public over lead tests
The former director of quality assurance at Magellan Diagnostics allegedly conspired with executives to conceal a critical flaw in lead tests they knew would result in tens of thousands of false negative tests among lead-exposed children.
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ArticleThe Cassava Sciences saga: Short sellers, ‘gaming’ the FDA, and the damaging ripple effects
The Federal Drug Administration’s decision last month to deny a citizen petition on behalf of short sellers with positions in Cassava Sciences stock highlights the damage the commonly exploited regulatory process can have on a company, regardless of innocence or guilt.
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ArticleCassava Sciences facing widening probe over short seller claims
The SEC has reportedly launched an investigation into Cassava Sciences regarding allegations made against the clinical-stage biopharmaceutical company and its experimental Alzheimer’s drug by a law firm representing anonymous short sellers.
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ArticleLegal precedent for COVID-19 vaccine mandates on shaky ground, expert says
Mandating COVID-19 vaccines for your workplace might not be as straightforward as following the legal precedent set by flu vaccines, an expert explained at CW’s “Compliance Considerations for the New Workplace” virtual summit.
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ArticleWhen manufacturing new product lines, be aware of new compliance risks
As companies around the world begin to manufacture products outside their comfort zone to address dire shortages in personal protective equipment amid the pandemic, compliance practitioners are negotiating new risks and challenges.
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ArticleBlockchain: The new frontier for supply chain risk management
A new pilot project currently being explored by the U.S. Food and Drug Administration has enlisted IBM, KPMG, Merck, and Walmart to help determine how to incorporate blockchain into pharmaceutical supply chains.
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BlogFDA Commissioner Scott Gottlieb to resign
Scott Gottlieb, commissioner of the Food and Drug Administration, announced Tuesday that he will resign within the next month.
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Blog
Ellison questions HHS hire from CVS Caremark.
Rep. Keith Ellison (D-Minn.) is asking Department of Health and Human Services Secretary Alex Azar for an explanation of the decision to hire CVS Caremark Vice President Daniel Best to lead the agency’s drug pricing reform effort.
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Blog
Pharmacy compliance director pleads guilty over mislabeled drugs
The former director of compliance for a compounding pharmacy company pleaded guilty last week to introducing adulterated drugs into interstate commerce and conspiracy to defraud the United States by obstructing the Food and Drug Administration’s lawful functions.