FDA Law Blog

OCTOBER 16, 2023

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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Maine Academy of Family Physicians

OCTOBER 22, 2023

207-938-5005 info@maineafp.org About About Board of Directors Member Spotlight Physician of the Year Presidents Statement Advocacy Advocacy Advocacy Opportunities in Maine Legislative Advocacy Advocacy Resources Health Equity Career Center Education/News Upcoming Events 33rd Annual MAFP FM Update - 2025 Newsletter - Current Newsletters - Past Resident & Student Interest Residency Programs Membership Practice Resources Billing & Coding Board Certification Direct Primary Care Licensing Req

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University of Utah Family Medicine Residency

OCTOBER 25, 2023

by Brian Bertsche, MD Future Medical Professionals, As you continue on your journey through medical school, the choice of your medical specialty is a pivotal decision. The allure of more high-profile specialties may seem appealing at first, but the ever-evolving field of family medicine should not be overlooked.

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The Clinical Problem Solvers

OCTOBER 24, 2023

[link] In this Infectious Disease Rafael Medina Subspecialty Episode, Dr. Navila Sharif presents a case to Dr. Natasha Spottiswoode of a patient presenting for fevers and chills. Session facilitator: Youssef Saklawi The goal of this series is to provide greater access to subspecialty, primary care, and internal medicine-adjacent specialty education for learners worldwide.

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East Cary Family Physicians

OCTOBER 20, 2023

Breast Cancer Awareness Month, celebrated every October, serves as a reminder of the significance of early detection, prevention, and support for those affected by breast cancer. At East Cary Family Physicians, we believe that knowledge is power. In this blog, we’ll explore the importance of Breast Cancer Awareness Month, focusing on early detection, prevention, and the vital role of regular screenings in women’s healthcare.

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Louisville Lectures

OCTOBER 18, 2023

Dr. Bryan Moffett presents "Sodium Derangements in the Medical Patient" by first differentiating the difference between total body sodium and sodium concentration. The then breaks down the physiology, causes, and treatment of hyponatremia. Watch the Video on YouTube Listen as a PodCast Watch Approach to Anemia and Acute and Chronic Diarrhea by Dr. Moffett BRYAN MOFFETT, M.D.

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PEMBlog

OCTOBER 11, 2023

Traumatic bladder rupture is a rare yet serious injury observed in children who have experienced blunt trauma. Signs include lower abdominal pain, ecchymosis across the abdomen, bloody urine, and the presence of free fluid on abdominal imaging following a high-energy impact. The bladder is a hollow organ and therefore is relatively protected when empty, which makes rupture uncommon.

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Clinical Correlations

OCTOBER 25, 2023

By Matthew Auda Peer Reviewed Let’s begin with a case. The patient is a 67-year-old female with a past medical history of hypothyroidism referred to your Cardiology Clinic by her primary care physician for cardiovascular disease.

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The Clinical Problem Solvers

OCTOBER 18, 2023

[link] Sharmin , Jack, and Maddy discuss their approaches to severe acute liver injury, abdominal pain, and hyperferritinemia as they talk through a case presented by Ann-Marie. Frameworks: Severe Acute Liver Injury Abdominal Pain To join us live on Virtual Morning Report (VMR), sign up HERE.

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Altitude Family & Internal Medicine

OCTOBER 10, 2023

Altitude Family & Internal Medicine (303) 730-2167 COVID-19: Fall and Winter 2023 Update COVID Fall and Winter 2023 Update Thanks for watching our latest COVID-19 Update. In this webinar, Dr. Hansen discusses: If you have enjoyed this webinar, next you may want to. This post COVID-19: Fall and Winter 2023 Update first appeared on Altitude Family & Internal Medicine (303) 730-2167 and is written by Doug Hansen.

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Maine Academy of Family Physicians

OCTOBER 28, 2023

ADDITIONAL RESOURCES FOR PHYSICIANS: (listing provided by Maine Medical Association - used by permission) How physicians can talk to patients about gun violence and firearm safety with Sandra Fryhofer, MD - VIDEO WITH Sandra Fryhofer, MD: [link] Access AMA's CME module to help prepare physicians to counsel their patients on firearm safety on the AMA Ed Hub.

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PEMBlog

OCTOBER 17, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. This year, in addition to the 10 finalists Maneesha Agarwal will be presenting at the National Conference and Exhibition we will be sharing four cases online in advance of the conference. This is the second of the four cases. This case was submitted by… A 6-year-old previously healthy female was brought to your emergency department with extremity pain. 4 days earlier, she developed r

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FDA Law Blog

OCTOBER 18, 2023

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. Such data may be needed to demonstrate substantial equivalence to a previously-marketed predicate device or, less frequently, to show that new or modified indications for use fall within the same intended use as the predicate device.

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Clinical Correlations

OCTOBER 6, 2023

By Zachary Henig Peer Reviewed Atherosclerosis is the primary risk factor for cardiovascular disease, the leading cause of mortality worldwide. To understand the pathophysiology of atherosclerosis, we turn to advances made in molecular biology. Understanding the.

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The Clinical Problem Solvers

OCTOBER 3, 2023

[link] Episode description: The spaced learning series team discusses a case of a patient with hyperbilirubinemia secondary to acute alcoholic hepatitis, who then developed hypoxia and hemolysis. Featuring: Anna Fretz Priyanka Athavale Kirtan Patolia Schemas Hyperbilirubinemia Hypoxemia Hemolysis Download CPSolvers App here RLRCPSOLVERS Click here to view the weekly episode recap email!

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GeriPal

OCTOBER 12, 2023

Summary Transcript Summary For surgeons and patients, deciding if and when to operate can be challenging. Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. And, surgeons often spend the majority of their conversations with patients describing anatomical details and exactly how they plan to ‘fix it’ , with little discussion of what that ‘fix’ will do for a patient’s overall goals.

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Maine Academy of Family Physicians

OCTOBER 22, 2023

6-week Medical Student Externship - Medical Student Externship Report – Molly Mann, MS2 2023 July – August "My externship experience consisted of shadowing Dr. Der Simonian at the Falmouth Family Medicine office and at the Maine Medical Center Mother Baby Unit. I also spent one day at the Maine Family Planning clinic in Augusta, shadowing the head clinician, Lindsey Piper, NP.

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PEMBlog

OCTOBER 16, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. This year, in addition to the 10 finalists Maneesha Agarwal will be presenting at the National Conference and Exhibition we will be sharing four cases online in advance of the conference. This is the first of the four cases. This case was submitted by… A 12-year-old female was brought to your emergency department by her mother for 1 month of diffuse abdominal and back pain.

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FDA Law Blog

OCTOBER 8, 2023

By Karla L. Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment.

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Family Physicians of Greeley

OCTOBER 2, 2023

One of the scariest things to ever hear is that you or a loved one has been diagnosed with cancer. Would you be surprised to learn that 1 in 8 women are diagnosed with breast cancer in their lifetime? Breast cancer is the most commonly diagnosed cancer In the United States. Every 2 minutes a woman is diagnosed with breast cancer. That’s right, by the time you are finished reading this, there will be 2 more women who will find out they have breast cancer.

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The Clinical Problem Solvers

OCTOBER 11, 2023

[link] Episode 305: Neurology VMR – Shallow breathing Episode description: We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, Vaness presents a case of shallow breathing to Maria and Sridhara. Neurology DDx Schema Vanessa Roque Vanessa, a proud Filipino through and through, has dedicated herself to medicine.

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GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. That’s why we do this podcast- to address real world issues in palliative care, geriatrics, and bioethics. But rarely does the podcast and clinical reality meet in the same day. Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition.

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East Cary Family Physicians

OCTOBER 9, 2023

As the leaves begin to change and the air takes on a crisper note, fall arrives with its unique set of health considerations. Amidst the familiar rituals of pumpkin spice and cozy sweaters, the fall season also marks the resurgence of respiratory threats. In this blog, East Cary Family Physicians explores the critical importance of fall shots, focusing on Respiratory Syncytial Virus (RSV), COVID-19, and the seasonal flu.

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PEMBlog

OCTOBER 26, 2023

Background Meckel diverticulum is a congenital abnormality of the small intestine and is the most common cause of significant lower gastrointestinal bleeding in children. It arises from incomplete involution of the vitelline duct during embryonic development, typically occurring by the 7th week of gestation. It is characterized by a blind-ending true diverticulum that contains all the layers found in the ileum.

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FDA Law Blog

OCTOBER 6, 2023

By Allyson B. Mullen & Gail H. Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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FDA Law Blog

OCTOBER 2, 2023

By Charles G. Raver & James E. Valentine & Frank J. Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy.

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PEMBlog

OCTOBER 18, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. This year, in addition to the 10 finalists Maneesha Agarwal will be presenting at the National Conference and Exhibition we will be sharing four cases online in advance of the conference. This is the first of the four cases. This case was submitted by… A four-day-old, full-term, exclusively breastfed male with benign prenatal and antenatal courses, presented with one day of decreased

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FDA Law Blog

OCTOBER 12, 2023

By Sara W. Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition. Industry has been asking for Suitability Petition reform for years, either by FDA or mandated by Congress, but, other than a few rejected bills , such requests have ba

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FDA Law Blog

OCTOBER 5, 2023

By Anne K. Walsh — DOJ has issued another “voluntary disclosure” policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition. Under this new policy, a company will receive a “presumption of declination” of agency action – i.e., a safe harbor – if it discloses misconduct discovered at the acquired company within six months before or after closing.

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FDA Law Blog

OCTOBER 4, 2023

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. The motion was based on the Plaintiffs’ Fifth Amendment due process argument: that absent preliminary relief, Plaintiffs and their members will suffer imminent, irreparable constitutional harm.

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FDA Law Blog

OCTOBER 26, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — In our June blog post , we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. FDA uses this program to help it identify risks and to determine whether further investigation is needed. Because this program requires information collection from the public, the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501) and its implementing

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FDA Law Blog

OCTOBER 24, 2023

By Philip Won & Allyson B. Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). The same template can also be used for De Novo submissions. Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

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PEMBlog

OCTOBER 16, 2023

EmergiQuiz is an annual case-based presentation sponsored by the AAP Section on Emergency Medicine that challenges the audience to think through the differential diagnosis for four amazing cases. Traditionally these cases are presented live at the AAP National Conference and Exhibition. Since 2020 the AAP Section on Emergency Medicine has also been sponsoring the publication of online cases on EmergiQuiz.com.

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PEMBlog

OCTOBER 12, 2023

After 6 wonderful years I have passed the duties of hosting PEMPix on to Maneesha Agarwal. She will do an amazing job presenting the 10 finalists at the Section on Emergency Medicine sessions at the AAP National Conference and Exhibition in Washington, DC on Saturday, October 21st from 12-1PM. As is tradition we will also be sharing 4 online cases in advance of the conference on PEMBlog.com.

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PEMBlog

OCTOBER 9, 2023

EmergiQuiz is an annual case-based presentation sponsored by the AAP Section on Emergency Medicine that challenges the audience to think through the differential diagnosis for four amazing cases. Traditionally these cases are presented live at the AAP National Conference and Exhibition. Since 2020 the AAP Section on Emergency Medicine has also been sponsoring the publication of online cases on EmergiQuiz.com.

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FDA Law Blog

OCTOBER 10, 2023

Hyman, Phelps & McNamara, P.C. (“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug Regulatory Expert. Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades. She is an oncologist/hematologist and at the time she retired from FDA on July 29, 2023, she was the Director of the CDER Office of Immunology and Inflammation (OII) in the Office of New Drugs

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FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.” Implant devices are used in a range of settings such as dental and orthopedic procedures.

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