by Darshan Kulkarni | Mar 27, 2017 | Advertising
Companies will need to be careful about the specific claims they make in their advertising. Method Pharmaceuticals inappropriately claimed that its generic product (Me-PB-Hyos) was a legal generic alternative and substitutable for Concordia Pharmaceuticals’...
by Darshan Kulkarni | Mar 23, 2017 | Advertising
States like Vermont have worked to disincentivize advertising by various bills including those that remove the tax deductions for pharmaceutical advertising. Oregon seems to have taken a slightly different approach.and hopes to require drug companies to list the...
by Darshan Kulkarni | Mar 23, 2017 | Pharmacy
I just saw this in the news and thought of you. As you know, various states are working to expand the role of pharmacists including by testing patients. Texas is about to go a step further and allow pharmacists to complete an ACPE authorized training program and then...
by Darshan Kulkarni | Mar 22, 2017 | Manufacturing
Hope you are doing well. I just came across this article and thought you may find it useful. In case you don’t want to read the whole article – President Trump has been a big fan of decreasing drug costs and believes that manufacturers are charging too...
by Darshan Kulkarni | Mar 21, 2017 | Clinical Trials
This come across my desk, and I wanted to make sure you saw it. Quick Synopsis in case you don’t want to read the article: President Trump has announced that he isn’t a fan of excessive government oversight. He believes that there are too many regulations...
by Darshan Kulkarni | Mar 20, 2017 | Legal & Regulatory
It seems like Advamed (which represents various medical device companies) has reached out to the OIG (Office of Inspector General) to ask them to create new safe harbors for the Anti-Kickback provisions to allow for value based care. To find out more about how it may...
by Darshan Kulkarni | Mar 17, 2017 | Medical Marijuana
President Trump has been sending mixed messages on whether he will allow marijuana to be available on a state by state basis. On specific contention seems to be recreational marijuana, as opposed to medical marijuana, which seems to have a heightened chance of drawing...
by Darshan Kulkarni | Mar 16, 2017 | Compounding, Drugs, Pharmacy
As you may be aware, the State Board of Pharmacy in Pennsylvania has decided to update its compounding regulations and synchronize them with US FDA regulations. We are currently in the 30 day comment period. If you have questions about what this means to you , please...
by Darshan Kulkarni | Mar 15, 2017 | FDA, Manufacturing
The US FDA and the EU just announced that they intend to recognize each other’s manufacturing inspections. This will likely result in fewer and duplicative inspections but may result in more stringent audits. If you have any questions about how this impacts you,...
by Darshan Kulkarni | Mar 13, 2017 | Advertising, Medical Affairs
I just had this come across my desk and thought you may be interested. As you know, several advocates and government officials have come out against drug advertising and are looking for ways to penalize such communications. The most recent non binding resolution calls...
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