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.
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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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.
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.
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.
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.
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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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.
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
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.
FDA Law Blog
OCTOBER 9, 2023
By Faraz Siddiqui & Sophia R. Gaulkin & Jeffrey N. Wasserstein — The U.S. District Court for the District of Columbia has vacated the Notice of Benefits and Payment Parameters (NBPP) rule issued in May 2020 (2020 NBPP Rule) which allowed health insurers and pharmacy benefit managers to use copay accumulators to exclude drug manufacturers’ copay assistance when calculating patients’ out-of-pocket costs and cost-sharing ceilings under the Affordable Care Act (ACA).
FDA Law Blog
OCTOBER 11, 2023
By James E. Valentine & Charles D. Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” This final guidance replaces and supersedes the March 2020 guidance entitled, “ Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency.
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