DarshanTalks Podcast show

DarshanTalks Podcast

Summary: Regulatory guy. Irregular podcast.

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Podcasts:

 Do I Need to Register My Dietary Ingredient with the FDA? | File Type: audio/mpeg | Duration: 00:03:45

Dietary ingredients are required to be registered with the FDA, but the process of registration can be complicated. What should companies keep in mind? Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 Do Anti-Aging Creams Work? | File Type: audio/mpeg | Duration: 00:08:35

Cosmetic products are often advertised with claims that can be misleading or exaggerated. This is because, unlike drugs, cosmetics are less regulated by the FDA. Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 Research vs Medicine | File Type: audio/mpeg | Duration: 00:06:52

Clinical research and medical treatment are often confused for one another, leading drug companies and healthcare professionals to risk falling out of compliance. Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 How to Register My Dietary Supplement with the FDA | File Type: audio/mpeg | Duration: 00:03:36

Dietary supplements and ingredients are required to be registered with the FDA, but the process of registration can be complicated. What should companies keep in mind? Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 Cannabis Law Basics | File Type: audio/mpeg | Duration: 00:11:04

As more states move to decriminalize cannabis, the regulatory framework becomes more complicated. How can companies successfully navigate federal and state laws? Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 What is the OTC Monograph Process? | File Type: audio/mpeg | Duration: 00:04:57

Drug manufacturers developing OTC drugs have a lot of important decisions to make. One of these decisions is determining which regulatory pathway works best for their product. Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 Patient Centricity: Drug Snapshot | File Type: audio/mpeg | Duration: 00:09:44

There is growing pressure from patients to make healthcare more transparent. However, there remain privacy concerns about publicizing clinical research data. Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 How the FDA Got Her Groove Back (With CBD Warning Letters) | File Type: audio/mpeg | Duration: 00:14:07

The FDA issued warning letters to several CBD companies for selling unapproved products with unsubstantiated medical claims. Let me know your thoughts on Twitter with #DarshanTalks: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 Setting up an Investigational Drug Pharmacy | File Type: audio/mpeg | Duration: 00:20:34

Setting up compliant investigational drug pharmacies means reviewing FDA requirements and ensuring regulations are being met. Leave a comment and let me know your thoughts. Get in touch with me on Twitter: twitter.com/darshantalks Website: www.Darshantalks.com Law Firm: www.kulkarnilawfirm.com Sign up for my newsletter: 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

 Why Should We Care About Bioethics? | File Type: audio/mpeg | Duration: 00:15:06

A grey area within bioethics presents some very challenging questions as it becomes increasingly harder to distinguish what is moral and immoral in the realm of science. 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

 Responding to an FDA Inspection - Part 1 | File Type: audio/mpeg | Duration: 00:05:42

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

 Responding to an FDA Inspection - Part 2 | File Type: audio/mpeg | Duration: 00:06:29

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

 Responding to an FDA Inspection - Part 4 | File Type: audio/mpeg | Duration: 00:09:42

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

 Responding to an FDA Inspection - Part 3 | File Type: audio/mpeg | Duration: 00:09:45

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

 Addressing the Opioid Crisis | File Type: audio/mpeg | Duration: 00:05:29

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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