Beste FDA podcaster (2024)

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Trailer 2:51

15d ago2:51

2:51

Welcome to FDA Watch, a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. Hosts Shelly Garg and Wayne Pines will dive into compelling conversations with a diverse array of FDA-focused professionals, who shed light on the develo…

1
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause 3:30

3M ago3:30

3:30

Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause.

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FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) 4:00

11M ago4:00

4:00

Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).

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Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity 3:30

11M ago3:30

3:30

Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.

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FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) 5:05

1y ago5:05

5:05

Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).

1
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions 5:30

1+ y ago5:30

5:30

Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

1
FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use 7:30

1+ y ago7:30

7:30

Listen to an audio podcast of the April 13, 2023, FDA Drug Safety Communication, FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use.

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Tell Me Lies, Tell Me Sweet Little Lies: FDA Is Not My Only Potential Headache When It Comes to Product Promotion 29:29

2y ago29:29

29:29

In this episode, Alan G. Minsk, AGG Food & Drug team leader, and Anuj Desai, AGG Intellectual Property partner and head of Trademarks, discuss recent developments that remind our audience in the food and drug space that FDA is not the only regulatory agency that’s keeping an eye on the marketplace. Alan and Anuj look at how NAD, a BBB program that …

1
FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab) 4:00

2y ago4:00

4:00

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

1
FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib) 4:00

2+ y ago4:00

4:00

Listen to an audio podcast of the June 30, 2022, FDA Drug Safety Communication. Results from a clinical trial show a possible increased risk of death with Copiktra (active ingredient duvelisib) compared to another medicine to treat leukemia and lymphoma.

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FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns 2:00

2+ y ago2:00

2:00

Listen to an audio podcast of the 6/1/22 for Ukoniq . FDA withdrew its approval for the cancer medicine Ukoniq (active ingredient umbralisib) due to safety concerns. Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL)

1
FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging 4:30

2+ y ago4:30

4:30

Listen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media

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FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib) 3:30

3y ago3:30

3:30

Listen to an audio podcast of the February 3, 2022, FDA Drug Safety Communication, FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). We are re-evaluating this risk against the benefits of Ukoniq for its approved uses.

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FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain 5:59

3y ago5:59

5:59

Listen to an audio podcast of the January 12, 2022, FDA Drug Safety Communication warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.

1
FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury 4:00

3y ago4:00

4:00

“Listen to FDA Drug Podcast, FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury

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Business Divorces in the Food and Supplements Space 23:13

3y ago23:13

23:13

In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business divorces or disputes between companies in the food and supplements space. They will discuss, among other things, post-divorce prod…

1
FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions 4:00

3+ y ago4:00

4:00

Listen to an audio podcast of the September 1, 2021 FDA Drug Safety Communication on requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.

1
FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins 3:00

3+ y ago3:00

3:00

Listen to an audio podcast of the July 20, 2021 FDA Drug Safety Communication, FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

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Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply from an FDA and Corporate Perspective 12:31

3+ y ago12:31

12:31

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and Genevieve M. Razick, an attorney in our Healthcare and Food & Drug practices, along with Leah D. Braukman, an attorney in our Corporate & Finance practice, discuss the specifics of the small business user fee waiver, who qualifies, and how to apply from an FDA and corporate perspect…

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FDA warns that vapors from alcohol-based hand sanitizers can have side effects 4:29

3+ y ago4:29

4:29

Listen to an audio podcast of the June 16, 2021 Drug Safety Communication "FDA warns that vapors from alcohol-based hand sanitizers can cause symptoms such as headache, nausea, and dizziness after applying to the skin"

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Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis 3:00

3+ y ago3:00

3:00

Listen to FDA Drug Safety Podcast on due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis

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Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease 3:00

3+ y ago3:00

3:00

Listen to an audio podcast of the March 31, 2021 FDA Drug Safety Communication that FDA review of studies show a potential increased risk of heart rhythm problems, in patients with heart disease taking lamotrigine (Lamictal). FDA requiring studies to evaluate heart risk across the drug class.

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FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm 3:00

3+ y ago3:00

3:00

Listen to an audio podcast of the March 25, 2021 FDA Drug Safety Communication warning that abuse and misuse of the over the counter (OTC) nasal decongestant propylhexedrine (brand name Benzedrex) can lead to serious harm such as heart and mental health problems.

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Data Privacy Issues Life Sciences Companies May Encounter 19:47

4y ago19:47

19:47

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG’s Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may encounter such as privacy policies, the patchwork of federal and state privacy and data security laws in the U.S., international dat…

1
Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) 3:00

4y ago3:00

3:00

Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "Initial safety trial results find increased risk of serious heart-related problems and cancer with tofacitinib (Xeljanz, Xeljanz XR)

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FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: 2020 Year in Review 20:31

4y ago20:31

20:31

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick, give an overview of FDA’s Office of Prescription Drug Promotion’s (OPDP) enforcement of unlawful advertising in 2020.Av Arnall Golden Gregory LLP

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FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment 39:58

4y ago39:58

39:58

In this episode, partner Kevin M. Bell and of counsel Bob Durkin discuss some of the more interesting issues and challenges they have encountered when working with clients to ensure they maximized opportunities to monetize the greatest value from their natural products and how a well thought out and executed regulatory strategy can help.…

1
Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely 28:51

4y ago28:51

28:51

In this episode, partner Anuj Desai and of counsel Carolina M. Wirth discuss the Federal Trade Commission (FTC) and Food and Drug Administration's (FDA) roles of protecting consumers at the height of a public health crisis and the types of advertising and legal compliance issues that have surfaced in the past several months as well as provide a rec…

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Key Due Diligence Issues to Consider When Acquiring or Investing in Life Sciences Companies or Products 24:31

4y ago24:31

24:31

In this episode, Alan G. Minsk, partner and leader of the Food & Drug practice team, is joined by Brian A. Teras, partner of the Corporate & Securities practice team. They provide an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process.…

1
FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid 3:00

4y ago3:00

3:00

Listen to an audio podcast of the October 15, 2020 FDA Drug Safety Communication titled "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. This issue affects all NSAIDs availbale by prescription and over-the-counter (OTC)."

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Quality Agreements for FDA-Regulated Products: Looking Under the Hood 27:21

4y ago27:21

27:21

In our inaugural episode, Alan G. Minsk, partner and leader of the Food & Drug practice team, is joined by Michael E. Burke, co-chair of the Pharmaceuticals & Biologics industry team. They discuss issues around quality agreements for FDA regulated products as well as topics related to manufacturing, FDA timelines and compliance with relevant nation…

1
FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl) 3:00

4y ago3:00

3:00

Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "FDA warns about serious Problems with high doses of the allergy medicine diphenhydramine (Bendaryl).

1
FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class 3:00

4y ago3:00

3:00

Listen to an audio podcast of the September 23, 2020, FDA Drug Safety communication to address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions as FDA required the Boxed Warning be updated for all benzodiazepine medicines.

1
FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) 3:00

4+ y ago3:00

3:00

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

1
FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder 3:00

4+ y ago3:00

3:00

Listen to an audio podcast of the 07.23.2020 FDA Drug Safety Communication: FDA recommends HCPs discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder

1
FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems 3:32

4+ y ago3:32

3:32

Listen to an audio podcast of the April 24, 2020 FDA Drug Safety Communication: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Close supervision is recommended

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FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market 3:00

5y ago3:00

3:00

Listen to an audio podcast of the February 13 2020 FDA Drug Safety Communicationrequesting the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Potential risk of cancer outweighs the benefits.

1
FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems 3:00

5y ago3:00

3:00

Listen to an audio podcast of the January 28, 2020 FDA Drug Safety Communication that FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications.

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Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin) 2:00

5y ago2:00

2:00

Listen to an audio podcast of the January 14, 2020 FDA Drug Safety Communication titled "Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin).

1
FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) 3:00

5y ago3:00

3:00

Listen to an audio podcast of the December 19, 2019 FDA Drug Safety Communication warning that serious breathing difficulties may occur in patients using seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.

1
FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease 3:00

5+ y ago3:00

3:00

Listen to an audio podcast of the August 28, 2019 FDA Drug Safety Communication: FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi with advanced liver disease.

1
FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) 3:00

5+ y ago3:00

3:00

Listen to an audio podcast of the July 26, 2019 FDA Drug Safety Communication on FDA approval of Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR).

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FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines 3:00

5+ y ago3:00

3:00

FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

1
Fdai program 2:37

5+ y ago2:37

2:37

Mari is one of teacher who has a great opportunity to be a participant in FDAI program.

1
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering 3:00

5+ y ago3:00

3:00

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

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الأدوية خلال الحمل | بودكاست غذاء ودواء 4:46

6y ago4:46

4:46

تدور محاور الحلقة حول الأدوية خلال الحمل، وأصنافها حسب مأمونيتها، وما حادثة دواء "الثاليدوميد"؟، وأيضًا عن مخاطر استخدام دواء "آيزوتريتينوين" أثناء أو قبل الحمل، وأهم النصائح لاستخدام الأدوية خلال أو قبل الحمل.حيث يستضيف المدير التنفيذي للتواصل والتوعية الأستاذ عبدالرحمن السلطان الدكتور تركي الثنيان أخصائي أول تقييم دوائي.الأستاذ عبدالرحمن السلطانh…

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المضادات الحيوية | بودكاست غذاء ودواء 4:56

6y ago4:56

4:56

تدور محاور الحلقة المضادات الحيوية، وما الذي يميزها عن غيرها من الأدوية؟، وهل يمكن استخدامها لنزلات البرد أو الإنفلونزا؟، وأيضًا يتحدث عن كيفية تكون البكتيريا المقاومة للمضادات الحيوية، وبالأخير يتحدث عن جهود الهيئة لمنع تكوّن ظاهرة البكتيريا المقاومة للمضادات الحيوية.حيث يستضيف المدير التنفيذي للتواصل والتوعية الأستاذ عبدالرحمن السلطان الدكتور محم…

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الأعراض الجانبية وكيفية الإبلاغ عنها | بودكاست غذاء ودواء 4:45

6y ago4:45

4:45

تدور محاور الحلقة حول الأعراض الجانبية للأدوية، وهل تحدث مباشرة بعد استخدام الدواء؟، وهل من الممكن أن تظهر أعراض جانبية غير مذكورة في النشرة الداخلية للدواء؟، وأيضًا عن دور المركز الوطني للتيقظ والسلامة الدوائية في الأعراض الجانبية للأدوية.حيث يستضيف المدير التنفيذي للتواصل والتوعية الأستاذ عبدالرحمن السلطان الصيدلي مبارك الشهراني رئيس قسم جمع البي…

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الأخطاء الدوائية | بودكاست غذاء ودواء 4:51

6y ago4:51

4:51

تدور محاور الحلقة حول الأخطاء الدوائية، وأبرز الأمثلة عليها، وعن الأسباب الأكثر شيوعًا له، وبالأخير عن أهم النصائح حول الأخطاء الدوائية.حيث يستضيف المدير التنفيذي للتواصل والتوعية الأستاذ عبدالرحمن السلطان الدكتور عبدالعزيز الدريهم مدير إدارة الأخطاء الدوائية.الأستاذ عبدالرحمن السلطانhttps://www.twitter.com/asalsultan…

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سلامة الأغذية خارج المنزل | بودكاست غذاء ودواء 5:12

6y ago5:12

5:12

تدور محاور الحلقة حول كيفية الحفاظ على سلامة الغذاء، وما أنواع الأغذية سريعة الفساد، وأيضًا عن الطرق الصحيحة لنقل الأغذية سريعة الفساد خارج المنزل، وكذلك الطرق الصحيحة لحفظ الطعام خارج المنزل، وأهم النصائح والإرشادات عند شوي الطعام.حيث يستضيف المدير التنفيذي للتواصل والتوعية الأستاذ عبدالرحمن السلطان الأستاذ محمد الهذيل مدير إدارة تقييم المخاطر.الأ…

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