DarshanTalks Podcast show

DarshanTalks Podcast

Summary: Regulatory guy. Irregular podcast.

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Podcasts:

 10 Ways to Communicate With the FDA | File Type: audio/mpeg | Duration: 00:05:08

Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 8 Ways to Bring a Product to Market Without FDA Approval | File Type: audio/mpeg | Duration: 00:09:01

Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Anti-Kickback Settlement Surge | File Type: audio/mpeg | Duration: 00:09:15

Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Insys & Mallinkrodt: Is legal really necessary on your promotional review teams? | File Type: audio/mpeg | Duration: 00:05:36

Insys admits to orchestrating a nationwide sham "speaker program" and Mallinckrodt raises drug price by over 100,000% (not a typo) and bribes docs to prescribe. Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: twitter.com/darshantalks LinkedIn: www.linkedin.com/in/darshankulkarni/ Google Play: play.google.com/music/m/Ioklyrkup…shanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Types of Ethics | File Type: audio/mpeg | Duration: 00:17:23

Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Diving Deeper Into Understanding Bioethics | File Type: audio/mpeg | Duration: 00:09:51

Prescriptive rights and utilitarianism as it applies to bioethical decision making Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 ENDS Product Marketing: FDA releases guidance on marketing vaping products | File Type: audio/mpeg | Duration: 00:14:07

Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 23 & me and Ethical Engagement | File Type: audio/mpeg | Duration: 00:19:02

23 and me sold your data to Glaxo Smith Kline ( GSK ) for $500 million. Is this ethically justified? Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/listen?u=0#/ps/Ioklyrkupu6g2iswf5eiim46afe

 Stem Cell Clinics | File Type: audio/mpeg | Duration: 00:05:41

Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 FDA and Vaping: Influencer Marketing Warning | File Type: audio/mpeg | Duration: 00:09:59

E-cig companies are traversing the wild west of regulations... Check out my weekly curated content here: http://recentrecap.darshankulkarni.com/ Leave a comment and tell me what you think. ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Alzheimers and the New Dawn of Snake Oil Salesman | File Type: audio/mpeg | Duration: 00:04:41

Snake oil salesmen still exist, and they're worse than ever. Check out my weekly curated content here: http://recentrecap.darshankulkarni.com/ Leave a comment and tell me what you think.

 FDA Warning Letter: Vivus | File Type: audio/mpeg | Duration: 00:04:20

I've heard Ad Agencies say that an FDA Warning Letter is a badge of honor because it shows that you "push the envelope." ...but is pushing the envelope worth further FDA scrutiny? ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Government Shutdowns & Patient Centricity | File Type: audio/mpeg | Duration: 00:19:52

During a government shutdown, to what extent are patients considered? Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 CBD: FDA Hearing | File Type: audio/mpeg | Duration: 00:06:01

Check out and signup for my newsletter: http://recentrecap.darshankulkarni.com/issues/recent-recap-issue-16-180552 ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

 Minimizing Participant Loss in Clinical Trials - Part 2 | File Type: audio/mpeg | Duration: 00:12:04

Clinical Trial enrollment is the first hurdle. Here's how you get participants to stay. Website: http://www.Darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Sign up for my newsletter: http://recentrecap.darshankulkarni.com/ Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Google Play: https://play.google.com/music/m/Ioklyrkupu6g2iswf5eiim46afe?t=DarshanTalks_Podcast ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. 5. This does not create an attorney-client relationship

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