Medicare: Brady Releases Draft Legislation to Combat Fraud
On August 7, 2014, Ways and Means Health Subcommittee Chairman Kevin Brady (R-TX) Brady released a discussion draft of legislation entitled “The Protecting Integrity in Medicare Act of 2014” (PIMA)....
View ArticleNYSBA Food, Drug and Cosmetic Section Annual Meeting Features Medical Device...
On January 29, 2015, the Food, Drug and Cosmetic Law Section (FDC Section) of the New York State Bar Association (NYSBA) will hold its Annual Meeting at the New York Hilton Midtown, New York City....
View ArticleFDA Lawyer Epiphany: Lawyers Helping FDA
So I had an epiphany last night—I was thinking about why more FDA lawyers do not get involved in helping Congress or FDA with developing legislation, regulations, and guidances to help FDA do its...
View ArticleEGA’s 11th Legal Affairs Forum in Brussels Later This Week: Still Time to...
Later this week in Brussels, Belgium, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum. The Forum will be held on March 26-27, 2015 utilizing an...
View ArticleEU Medical Device Update
There is progress on the two new European Union (EU) regulations on medical devices and in vitro diagnostic medical devices. On June 19, 2015, the Council of the EU (led by Latvia, at the time the...
View ArticleEU Rules on Medical Devices Reached Sooner than We Thought
On May 25, 2016, the various European Union (EU) negotiators have finally reached a deal (four years in the making) on new rules for medical devices and in vitro diagnostic medical devices (see EU...
View ArticleREMS and Restricted Drug Distribution – FDA Regulatory and Antitrust Program...
On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, will put on a program in New York City: “REMS and Other Drug Distribution...
View ArticleNYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an...
On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When...
View ArticleSusan Winckler Featured Keynote Speaker This Week at 8th Annual...
On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago. Kicking off the Conference...
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