The FDA announced on January 12 that they propose delaying “indefinitely” the publication of final rules on regulations describing the evidence that may be considered in determining a medical product’s intended uses. (21 CFR 201.128—drugs and 21 CFR 801.4—devices.)
I love my work on Promotional Review Committees. The (usually) collaborative nature of the process is satisfying, and I get to combine my legal practice with my pre-law technical communications experience (also known as “Engineers for Dummies”). And since I’ve been on the Marketing side of the table, I absolutely get that “No!” […]
On December 22, 2017, after vigorous public hearings and comments, New Jersey adopted new rules limiting pharmaceutical manufacturer payments to prescribers to $10,000 per year and imposing a $15 meal cap. The law goes into effect January 15, 2018.
Governor Christie first proposed the rule on International Opioid […]