FDA: “intended use” same as it ever was

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.)

According to the Federal Register notice, comments and a petition […]

By |2018-05-18T14:54:12+00:00January 24th, 2018|

New Jersey imposes strict payment and meal limits for prescribers

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 […]

By |2018-01-10T15:15:17+00:00January 9th, 2018|