All FDA 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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ArticleCompliance takeaways from FDA’s final ‘intended use’ rule
The U.S. Food and Drug Administration’s “intended use” final rule reaffirms the agency’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies.
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ArticleCOVID-19 vaccine mandates no less tricky after FDA approval
Determining the best way to get your employees vaccinated against COVID-19 means considering a handful of key issues, in addition to being prepared for difficult conversations.
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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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ArticleFTC, FDA to enhance antitrust oversight in biologics market
The Federal Trade Commission and Food and Drug Administration have signaled they will be increasing their oversight of any potential antitrust behavior in the biologics market.
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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 singles out Walgreens in nicotine sales crackdown
The FDA is escalating a “forceful” crackdown on retailers and manufacturers that sell nicotine-based products to minors. Among the companies in its crosshairs: Walgreens.
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Blog
FDA, DHS partner on medical device cyber-security
The Food and Drug Administration and Department of Homeland Security have announced a new framework for greater coordination and cooperation when addressing cyber-security in medical devices.
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Blog
FDA will publicly scold drug companies that try to derail generics
The FDA’s new tactic for driving down prescription drug costs: publicly shaming them by “shining a light on situations where drug makers may be pursuing gaming tactics to delay generic competition.” Drug companies that try to scuttle generic competition will be named on the FDA’s Website.
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Blog
FDA rule for mandatory nutrition labels goes into effect
The Food and Drug Administration has chosen not to block or further delay the May 7 compliance date for requirements that restaurants, supermarkets, convenience stores, and movie theaters list calorie information on all menus and menu boards.
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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.
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Blog
Gottlieb approved as FDA commissioner
President Donald J. Trump’s pick to head the Food and Drug Administration, Dr. Scott Gottlieb, was confirmed this week by a 57-42 vote in the Senate.
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Article
The EpiPen controversy’s bad omens for pharmas
At a recent hearing with the CEO of Mylan, the maker of EpiPen, legislators hinted at not only price controls, but an increased scrutiny of executive pay. Joe Mont has more.
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BlogEuropean Medicines Agency issues draft guidance on data integrity
The European Medicines Agency and the Pharmaceutical Inspection Co-operation Scheme have released draft guidance for pharmas on how to maintain data integrity during testing, manufacturing, packaging, distributing, and monitoring of medicines. Jaclyn Jaeger reports.
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Article
Calls for More Data Sharing to Step Up Terrorism Fight
Washington wants Corporate America to step up its attention to terrorism risk. That was the message at a recent congressional hearing, the latest instance of voices saying business and government should cooperate to uncover terrorists’ sophisticated financing schemes. “Most of the early warning signs reside with the private sector, and ...
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Article
Drug, Device Companies Face New FDA Electronic Submissions
The Food and Drug Administration is overhauling how it accepts submissions for a host of filing requirements imposed on drug and medical device makers. For many, this will be the first time the submissions have ever been filed electronically. While the move away from paper documents may ultimately be advantageous ...
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Article
FTC, FDA Take Closer Look at Disclosures
The Federal Trade Commission is cracking down on companies with questionable advertising disclosures. The Food and Drug Administration, meanwhile, may allow shorter lists of side effects in drug and medical device ads, even as it prepares tougher standards for how these companies use online advertising and social media. The focus ...