For the Record

Thursday, June 13th, 2013
There are a number of factors to take into account when responding to FDA enforcement actions.
Thursday, May 23rd, 2013
Planning in advance for an FDA inspection of your compounding pharmacy will help prevent rash decisions after the inspectors walk in the door.
Friday, May 10th, 2013
The meningitis outbreak caused by a Massachusetts compounding pharmacy has set off a debate of whether and how regulation of compounders should be tightened.
Friday, October 26th, 2012
The fungal meningitis outbreak linked to a Massachusetts-based compounding pharmacy has led to a debate over how regulations can be improved to prevent such incidents in the future.
Thursday, May 10th, 2012
The FDA is considering giving pharmacists the power to dispense without a prescription certain medications that currently require a prescription.
Wednesday, March 28th, 2012
By insisting that certain medications only be used for their approved indications, the FDA opens itself up to accusations of overreach.
Thursday, November 3rd, 2011
The blockbuster drug Lipitor is about to go over-the-counter, which can lead to the loss of billions of dollars. Will converting save the brand?
Friday, October 21st, 2011
Most of the solutions that have been proposed to eradicate the drug shortage are flawed. Better, more practical solutions are needed.
About
Darshan Kulkarni, Kulkarni Law firm
Blog Info
Darshan Kulkarni, a pharmacist and attorney based out of Kulkarni Law firm (Philadelphia, PA), will provide insights on the legal, regulatory, administrative, and ethical issues that can affect pharmacists in their everyday practice.
Author Bio
This blog will primarily focus on informing pharmacists about how the drugs that they dispense came to be in their hands—including the ethics, the arguments, the laws, and the drama. Among the topics covered are FDA regulations, drug development, clinical trial participation, compounding drugs, social media marketing, and pharmaceutical advertising. This blog will also discuss what pharmacists need to know about dispensing certain medications.

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory, and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years. He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products–Regulatory Considerations.

You can follow him on twitter at @FDALawyers (http://www.twitter.com/FDALawyers) or visit the Kulkarni Law Firm's Web site (http://www.conformlaw.com/).

Disclaimer
The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and/or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney–client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
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