Four Key Takeaways From FDA’s 2017 Enforcement Stats
As seen in Law360. The U.S. Food and Drug Administration this week quietly unveiled its enforcement statistics for fiscal year 2017, and the numbers show a dramatic decline in medical device warnings,...
View ArticleCongress Looks to Crack Down on Counterfeit Opioids
As seen in WPXI News. Members of Congress are looking for ways to crack down on one of the tools of the trade for criminals making dangerous, fake pills. A House committee investigating the opioid...
View ArticleProduct Liability Cases to Watch: Midyear Report
As seen in Law360. As the U.S. continues to grapple with a growing opioid drug epidemic, states and municipalities are increasingly filing suit against drugmakers on allegations they flooded markets...
View ArticleFSMA: What Every Food Industry Executive Should Do & Why
With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that...
View ArticleCanadaDrugs.com Still Has Manitoba Pharmacy License
As seen in CBC News. The online pharmacy at the centre of an extradition case to the United States is still licensed to operate in the province by the College of Pharmacists of Manitoba, which says...
View ArticleOpioids: A First For The FDA
On June 8, 2017, for the first time ever, the Food and Drug administration took “steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”...
View ArticleFDA Deadline Extension: Agricultural Water Standards Compliance
Demonstrating that submitting comments to the FDA can pay dividends, the FDA announced on June 6, 2017 that it will extend the compliance dates for agricultural water standards contained within the...
View ArticleOpioids: A Prescription for Liability
As a result of a change in prescribing guidelines in the 1990s, the U.S. saw a dramatic increase in the long-term use of opioids for chronic non-cancer pain. The prevailing view in the medical...
View ArticleDELAYED: The FDA’s Intended Use Rule
The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017. The FDA is delaying the effective date to invite public...
View ArticleFDA Provides a Healthy Extension to Comment on Healthy
In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term “Healthy” in the labeling of food products. The FDA published notice in the Federal...
View ArticleNaturally FTC Rules
FTC Finds “All Natural” and “100% Natural” Claims False and Misleading In April 2016, four companies[i] marketing skin care products online agreed to settle Federal Trade Commission (FTC) charges that...
View ArticleFDA Final Rule on the Submission of Import Data
On November 29, 2016, the Food and Drug Administration (FDA) issued a Final Rule on the Submission of Import Data in the Automated Commercial Environment (ACE). The final rule specifies certain data...
View ArticleDrug Law: Off-Label Use – a Paradigm Shift and a Moral Imperative
On December 16, 2016, the State Bar of Texas will host a Webcast on the FDA and Off-Label Uses of Medical Products. Coincidentally in the wake of the 2016 presidential election, the Food and Drug...
View ArticleWill the Election Affect the Menu Labeling Rule Section of the ACA?
The election is over and President-Elect Trump, the candidate who promised to repeal and replace the Patient Protection and Affordable Care Act a/k/a Obamacare (the ACA), will be sworn in on Friday,...
View ArticleFDA’s Off-Label Hearing Set for the Day after the 2016 Election
On September 1, 2016 the Food and Drug Administration (FDA) issued its Notice of Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (FDA’s...
View ArticleMitigation Strategies Protect Food Against Intentional Adulteration
On May 27, 2016, the Food and Drug Administration (FDA) published the seventh and final rule required under the Food Safety Modernization Act (FSMA), imposing new duties on domestic and foreign food...
View ArticleFDA is KIND about Healthy and Tasty
As the self-appointed protector of consumers’ ability to understand product labels, the FDA has again attempted to demonstrate what Mel Brooks made famous in his movie The History of the World, it’s...
View ArticleSanitary Food Transportation: New Rules May Require a Fresh Look
Prompted by the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 (FSMA), the Food and Drug Administration (FDA) issued a new rule entitled “Sanitary Transportation...
View ArticleTwo Cases: Wineries and Regulators Are a Unique Blend
Regulatory enforcement can threaten the existence of wineries and small producers. First, the financial costs of regulatory inspection can be high, and new laws and regulations have given the...
View Article$500 Million Dollar Verdict in J&J Ultamet Case: Too Much Green, Even For St....
On March 17, 2016, St. Patrick’s Day, a Dallas federal court jury saw green, awarding almost $500 million to five plaintiffs in a consolidated trial against DePuy Orthopedics and J&J over the...
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