AG/FDA Blog

OFW Law Launches New Health Industry Practice; Ladd Wiley Joins Firm as Principal and Chair of Practice

OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice.  The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery syst… Read More
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Employment Law: Title VII Protects LGBTs From Discrimination, Says 7th Circuit

In a ground-breaking ruling this week, the U.S. Court of Appeals for the 7th Circuit ruled in an en banc opinion that Title VII of the Civil Rights Act of 1964 protects workers from discrimination based on sexual orientation.  In Hively v. Ivy Tech… Read More
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Good Grammar Matters Under the Law

I have been accused by my children of being a “Grammar Nazi.”  After years of haranguing, they know better than to end a sentence with a preposition in my presence (and, hopefully, when I am not around).  Another of my pet peeves is the common… Read More
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FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulga… Read More
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Court to CPSC: Your Magnet Rule’s a Turkey

Zen Magnets, the tiny Colorado company that has challenged the CPSC’s actions regulating small, powerful magnets, will be having a very good Thanksgiving this year.  That is because, once again, Zen has shown it is possible to fight the federal g… Read More
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A Course Correction at the CPSC?

Wow! Last Tuesday was quite something! Throughout Washington, folks are now trying to figure out what the new Administration will mean for our country.  But so far I have not seen anything written about what the CPSC will look like going into 2017,… Read More
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President-Elect Trump and NAFTA

Donald Trump’s “Contract with the American Voter” lists a number of actions that he plans to take in his first one hundred days in office.  Among those actions is to “announce my intention to renegotiate the NAFTA or withdraw fr… Read More
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FDA Issues Final Guidance on VQIP

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Imp… Read More
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Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act.   See generally Foo… Read More
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Splitting Headaches for Slack-Fill Plaintiffs

“Take two Advil® and don’t call me in the morning.” That might be the “prescription” that lawyers at a New York plaintiffs’ firm gave to their clients after reviewing an October 18, 2016, decision by Senior District Court Judge Sterling… Read More
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