Sat.Mar 02, 2024 - Fri.Mar 08, 2024

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Coming Soon: Logansport Memorial Pain Management Center

Logansport Memorial Hospital

Logansport Memorial Hospital is pleased to announce the opening of a new pain management center on April 1, 2024. The Logansport Memorial Pain Management Center will be located at 1201 Michigan Avenue, Suite 70, Logansport, IN 46947. Chronic pain can affect all areas of our lives, including our relationships, sleep, and mental health, and it may even lead to a lower quality of life.

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Four Types of Colon Cancer Screenings

Boulder Medical Center

Board-certified gastroenterologist Christie Blanton, MD, explains colon cancer screenings, from non-invasive stool tests to colonoscopies. The post Four Types of Colon Cancer Screenings appeared first on Boulder Medical Center.

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#HPMParty is returning to Phoenix during the 2024 AAHPM/HPNA meeting

GeriPal

The #HPMParty is returning to Phoenix during the 2024 AAHPM/HPNA meeting. We will be doing our traditional Pub Crawl, this time in the Roosevelt Row Arts District just north of the convention center. We’ll start our annual tour of local establishments at Luckys Indoor/Outdoor (817 N. 2nd Street) at 8pm on Thursday, March 21st (we moved it up from our traditional 9pm start to give a little extra time for those coming from the east coast.

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Episode 323: Neurology VMR – Visual Hallucinations

The Clinical Problem Solvers

[link] Episode title: Episode 323: Neurology VMR – Visual hallucinations Episode description: We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, Valeria presents a case of visual hallucinations to Greg and Umbish. Neurology DDx Schema Valeria Roldan @valeroldan23 Valeria Roldan was born and raised in Lima, Peru.

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Patient Testimonial: Dee Hensel

Logansport Memorial Hospital

When it comes to wound care, stress can play a major factor in your healing journey. For many, being in a clinical setting can spike stress and anxiety. It’s important to be able to trust your caregivers, and here at Logansport Memorial, we go above and beyond to develop relationships with our patients and provide personalized, high-quality care for our community.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog

By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Back for a Rant

Adventures of a Sick Doctor

I haven’t written anything here for a long time, and it’s hard to say what is the real prompt for me to break my silence today, but here goes. When I was busy having various cancer adventures, I always felt better after I spewed out all my thoughts and worries onto the keyboard. It’s funny how much easier it was to be open about my fears and concerns about cancer, than it is to talk about anything in the ordinary humdrumness of life.

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Episode 322: Antiracism in Medicine – Episode 24 – Leveraging Narrative Medicine to Cultivate Antiracist Praxis

The Clinical Problem Solvers

[link] CPSolvers: Anti-Racism in Medicine Series Episode 24 – Leveraging Narrative Medicine to Cultivate Antiracist Praxis Show Notes by Sudarshan Krishnamurthy February 13, 2024 Summary : This episode highlights the ways in which we might leverage stories, at the individual and structural levels, to reimagine medicine with a liberatory practice.

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Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog

By Steven J. Gonzalez & JP Ellison — The most recent version of the BIOSECURE Act (the “Act”) was introduced in the U.S. House of Representatives ( H.B. 7085 ) and Senate ( S.B. 3558 ) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future.

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End-of-Life Doulas: A Podcast with Jane Euler, Beth Klint, and John Loughnane

GeriPal

Summary Transcript Summary Please join Eric and Alex in person for the GeriPal pub crawl at the AAHPM/HPNA annual assembly in Phoenix, Thursday night 3/21 8PM. Starting bar is Luckys Indoor/Outdoor. Check out the Pub Crawl GeriPal post for more info, and follow #HPMParty on Twitter to keep us as we crawl! ** In the last several years, I’ve seen more and more articles about end-of-life doulas ( like this NY Times article from 2021 ).

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15 Years Strong: Rare Disease Week’s Remarkable Journey of Support

FDA Law Blog

By Frank J. Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. recognition of Rare Disease Day. NORD’s announcement followed in the footsteps of European rare disease patient organization, Eurodis , who had celebrated the first Rare Disease Day the year before. Time flies when your goal is to support the thirty million people that suffer from rare diseases.

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FDA Grants A Registration Fee Waiver for Very Small, Broke Device Manufacturers

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.

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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. AstraZeneca, whose drug Farxiga was selected last September for negotiations for price applicability year 2026, claimed that the IRA violated AstraZeneca’s Fifth Amendment right to due process because it deprived the company of its investment-backed patent rights and comm

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The LDT Rule Takes Another Step to Finalization — and a Likely Lawsuit

FDA Law Blog

By Jeffrey N. Gibbs & Allyson B. Mullen — FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards being finalized – and to a likely judicial showdown. On March 1, the Office of Management and Budget (OMB) received the draft final LDT rule for review ( here ). The LDT rule has moved forward with astonishing speed, advancing from the release of the proposed rule on October 3, 2023 to OMB in less than five months.

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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. HP&M is proud to have our professionals participating in these important events. On March 20-21, Counsel John W.M. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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Traditional Meat Industry’s Beef With Alternative Protein Continues with the FAIR on Labels Act

FDA Law Blog

By Sophia R. Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. The animal product industry, particularly the beef industry and the dairy industry, has challenged naming of APPs using what they consider to be traditional meat terminology.

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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products

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HP&M Director Anne Walsh to Share Global Ad Promo Insights at the DIA Advertising and Promotion Regulatory Affairs Conference

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference. This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Ms. Walsh will contribute her extensive expertise in FDA regulatory matters to a session titled “Global Ad Promo and Enforcement Insights,” addressing the complex