The FDA has added a warning for Depo-Provera , and thousands of women are asking a hard question: why now? Worth paying attention to how this plays out. #healthlaw #patientrights #informedconsent #pharma #dt #darshantalks

FDA added a brain tumor warning to Depo-Provera. Thousands of women are suing, saying they were never properly warned. This case involves informed consent and what happens when safety warnings come late. Worth watching!

When a sponsor ends a trial early, who protects the site? I share key contract clauses every site should include to ensure they’re paid for all work and closeout activities. #clinicalresearch #clinicaltrials #sitecontracts #kulkarnilawfirm #klf

You don’t need 200 SOPs to satisfy the FDA. Learn which key SOPs matter most and how to keep them concise and effective. Click below. #clinicaltrials #SOPs #clinicaloperations #kulkarnilawfirm #klf

MoCRA is changing how cosmetics are regulated. I explain what the FDA now expects when it comes to serious adverse event reporting and how brands can stay inspection-ready. #MoCRA #adverseeventreporting #cosmeticregulations #kulkarnilawfirm #klf

When a sponsor ends a trial early, who protects the site? @darshantalks shares key contract clauses every site should include to ensure they’re paid for all work and closeout activities. #clinicalresearch #clinicaltrials #sitecontracts #kulkarnilawfirm #klf

MoCRA is changing how cosmetics are regulated. @darshantalks explains what the FDA now expects when it comes to serious adverse event reporting and how brands can stay inspection-ready. #MoCRA #adverseeventreporting #cosmeticregulations #kulkarnilawfirm #klf

Are your cosmetic records ready for an FDA inspection. I discuss how organized and accessible documentation protects your brand and ensures compliance. Watch now. #FDAcompliance #regulatorycompliance #safetysubstantiation #kulkarnilawfirm #klf

The FDA looks at your label. The FTC looks at everything else. I discuss how balancing FDA and FTC requirements helps brands maintain regulatory harmony between what’s printed on the package and what’s promoted online. Watch now. #klf #cosmeticregulations

Are your cosmetic records ready for an FDA inspection. @darshantalks discusses how organized and accessible documentation protects your brand and ensures compliance. Watch now. #FDAcompliance #regulatorycompliance #safetysubstantiation #kulkarnilawfirm #klf

Different ways a DTP Program can bill for products and some possible risks and benefits. **Not legal advice**

The FDA looks at your label. The FTC looks at everything else. @darshantalks discusses how balancing FDA and FTC requirements helps brands maintain regulatory harmony between what’s printed on the package and what’s promoted online. Watch now. #klf #cosmeticregulations

FDA in clinical research may tighten oversight like never before. I highlight the areas that could face scrutiny as AI scales compliance. Watch the full video to see what teams need to address now. #clinicalresearch #regulatoryaffairs #klf

FDA in clinical research may tighten oversight like never before. @darshantalks highlights the areas that could face scrutiny as AI scales compliance. Watch the full video to see what teams need to address now. #clinicalresearch #regulatoryaffairs #klf

I posted one newsletter and woke up to 1,100 subscribers and a bunch of messages saying it resonated. Insights from Inside is about cutting through the noise the future of health for CEOs and Board members. If that’s your jam, subscribe:

Hidden clauses in PI agreements can threaten your site’s stability. I discuss the top 5 risks to watch for and the steps to protect your clinical trials. Click below to learn more. https://t.co/ZxOHn3671f #clinicalresearch #researchsites #clinicaltrials #klf

DEI in clinical research may be facing a pause—but not a stop. In my DIA-published article, @darshantalks explores how shifting policies and legal pressures are reshaping inclusion efforts and what sponsors can do to stay prepared. Read now https://t.co/T1hMERl5UT #DEI #klf

🎃 Wishing you a Happy Halloween from KLF! May your day be filled with fun, laughter, and just the right amount of spookiness. Stay safe and enjoy the celebrations! 👻 #happyhalloween #trickortreat #kulkarnilawfirm #klf

Life sciences small deals are more complex than they appear, especially in today’s regulatory and political landscape. Nella Bloom and I discuss the opportunities, risks, and strategic considerations shaping today’s transactions.