by MajorH | Nov 30, 2017 | Recent Recap
Lawyers, Regulatory and Compliance Medtech complaint handling: Is there something to complain about? Judge Sets Oct. 17 for Next Industry Challenge to Nevada Price Law Insurers cutting back on drug coupons amid concerns over consumer costs Medical Devices FDA...
by MajorH | Nov 22, 2017 | Recent Recap
Executives 3D bioprint me: a socioethical view of bioprinting human organs and tissue Gottlieb would rather stay at FDA – and pharma would agree AstraZeneca EVP: Brexit is hindering our hiring Lawyers, Regulatory and Compliance Wisconsin counties join lawsuit against...
by MajorH | Nov 16, 2017 | Uncategorized
Executives A new compensation rule could cause difficulties for CEOs Johnson & Johnson Wades Into Death Penalty Debate For First Time Why Early Peeks at Drug Trials Are Giving Investors Whiplash Lawyers, Regulatory and Compliance Sued for Retweeting – Yes, That...
by MajorH | Nov 9, 2017 | Recent Recap
Executives FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirments A recent announcement by FDA commissioner Scott Gottlieb confirmed that a new guidance will soon be released regarding the loophole that allows companies to designate approved...
by Darshan Kulkarni | Oct 31, 2017 | Uncategorized
Executives An open letter to Jeff Bezos–you are needed to disrupt the health care sector Jeff Bezos has led a consumer goods retail revolution through his company, online giant Amazon. Could pharma be his next step? In the midst of reports that Amazon is reaching out...
by MajorH | Oct 26, 2017 | Podcast
Is Amazon Your Next Pharmacy? (3 part series) Presented by the Gavel & Pestle Podcast with Darshan Kulkarni, Pharm.D, MS, Esq. Show Notes Part I: Learn the lingo most often used by professionals in the pharmacy world. Players in the Pharmacy World: Drug pipelines:...
by Darshan Kulkarni | Mar 31, 2017 | Medical Marijuana
Seems like Wisconsin is interested in getting into the medical marijuana world business. Get in touch through the form below if you have questions about what this means for you: Name Email Address Message 6 + 2 =...
by Darshan Kulkarni | Mar 30, 2017 | Pharmacy
With the opioid crisis becoming as problematic as it has been, the State of New Jersey has enacted new legislation that limits the initial opioid prescription to a 5 day supply (instead of 7 days like many other states). This would not apply in cases like end of life...
by Darshan Kulkarni | Mar 29, 2017 | Manufacturing
There are continuing concerns that 6 generic drug manufacturers were engaged in price fixing of 2 drugs by suppressing trade, fraudulently boosting and altering prices and diminishing competition. Indiana has hence joined 39 other states in suing these manufacturers....
by Darshan Kulkarni | Mar 28, 2017 | Clinical Trials
The 21st Century Cures Act imposed certain timelines on the NIH to improve clinicaltrials.gov. The improvements would have enabled clinicaltrials.gov to provide better information to the various stake holders. However, these timelines have been missed and have been...
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