Thinking about joining a clinical trial? Most patients are told how their data can be used or explains who owns it. Patients deserve clear answers before they consent. #ClinicalTrials #PatientRights #HealthData

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

North Carolina opens grant applications for small businesses in research, tech development.

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

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!

I can’t get AI not to lie and have to doublecheck everything. Courts are already struggling with the mass use of AI despite it being untrustworthy. Yet here we are where FDA expands artificial intelligence capabilities with agentic AI deployment

The secret is out. The EU finally recognizes that they have made innovation difficult if not impossible. They are proposing the following. Personally, I don’t think it’s enough. What do you think?

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

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

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.

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:

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

🎃 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

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

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

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

DEI in clinical research may be facing a pause—but not a stop. In my DIA-published article, I explore how shifting policies and legal pressures are reshaping inclusion efforts and what sponsors can do to stay prepared. Read now https://t.co/tEy1IN4X4x #DEI #klf

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

What’s next for direct-to-patient engagement? I recap the major themes from the latest conference, highlighting trust, transparency, and protecting the physician-patient relationship. #patientengagement #DTP #pharmacompliance #kulkarnilawfirm #klf

Cosmetics companies face new registration requirements. I explain the new requirements for cosmetics companies to register facilities, submit product listings, and maintain compliance as they grow. Click below for details. #cosmeticscompliance #beautyindustry #klf