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Category Archives: FDA
Other commentators have noted that they believe that Judge Kavanaugh (“K”) does not like “Chevron deference” of the courts to the interpretation of agency regulations. I skimmed recent decisions and note, that in technical areas, the judge recognized that deference … Continue reading
Apart from the carnage wrought by the ever-expanding scope of s. 101 rejections and the tightening of the written description requirement, there were still a number of events/trends in 2017 to applaud or at least to note as “worthwhile.” I … Continue reading
Jay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes: On December 8, 2015, … Continue reading
In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked … Continue reading