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Co-editor, 2018 FDLI Food and Drug Cosmetic Act Statutory Supplement

USA - January 4 2018 Newly updated to incorporate the FDA Reauthorization Act of 2017 (FDARA), the FDCA Statutory Supplement, 2018 is the indispensable tool for FDA law...


Shrinking Regulation in the New Administration

USA - February 8 2017 Donald Trump campaigned on reducing regulation by identifying and removing all “needless job-killing regulations.” One particular pledge is...

John P. Gregg.


FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

USA - February 1 2017 On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological...

Watson, Natalie S..