FDA Law Blog

MAY 27, 2024

HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. She also specializes in medical device software and digital health. Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics.

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

SEPTEMBER 15, 2024

The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act. 2220, the Promoting and Respecting Economically Vital American Innovation Leadership Act (“ PREVAIL Act ”); and (2) S. inventors to compete.

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FDA Law Blog

NOVEMBER 6, 2022

2011), here , and United States v. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background. Borrasi, 639 F.3d

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FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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FDA Law Blog

JULY 24, 2023

Because the premise of FDA’s determination—that not needing to awaken to take a second dose will provide medical benefits to narcolepsy patients by improving their sleep architecture and reducing disrupted or fragmented sleep—it must be a comparative effectiveness finding.

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FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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The Health Policy Exchange

JANUARY 3, 2013

Remarkably, Medicare was fully implemented only 11 months after the bill's signing, overcoming obstacles such as hospital segregation in the South, resistance from physician organizations such as the American Medical Association, and the logistical issues involved in issuing insurance cards to 18 million eligible seniors.

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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Medical Xpress

JUNE 16, 2025

This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone. But the NTU team discovered that it is far more complex.

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GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications.

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Georgetown Pediatrics & Family Medicine

MARCH 16, 2022

200-400 AD) Metrodora, a Greek female physician, wrote On the Diseases and Cures of Women, the oldest medical text known to be written by a woman. Elizabeth Blackwell (1821-1910) British-born Elizabeth Blackwell is best known as the first woman to earn an medical degree (MD) in the US. Metrodora (c.

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GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Eric: And Alex, who do we have with us today? Jerry, welcome to GeriPal. Jerry: Great to be here.

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GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions.

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GeriPal

APRIL 14, 2022

It’s been around for a long time but is acting like the hot new kid in town. Just look at this year’s AAHPM meeting, where it felt like every other session was talking about how hot buprenorphine is right now. But does this drug really live up to the hype? Eric: And why Under Pressure. Alex: So we’ll see what these come out like. Right, Katie?

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GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. Because that really is what this is about. SPONSOR: .

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The Medical Futurist

JUNE 17, 2025

Ettinger, who died in 2011, went on to found the Cryonics Institute in Michigan where he, his mother and his first and second wives all now reside in metal flasks kept at −196 °C. And Ellen Ripley and the crew waking up in a cryotube used for interstellar travel in the Alien series? Traveling in cryosleep to Mars?

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GeriPal

APRIL 13, 2023

Summary Transcript Summary Social connections impact our health in profound ways, whether it is the support we receive from family and friends in navigating serious illness, the joy from shared social activities, or connecting with our community. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great.

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FDA Law Blog

NOVEMBER 14, 2024

Nonetheless, the medical products sector historically has drawn the lion’s share of attention at FDA, with the agency’s leadership ranks reflecting that priority. However, it’s fair to say that FDA’s food program has focused primarily on implementation of the many mandates in the Food Safety Modernization Act of 2011.

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Medical Xpress

JUNE 8, 2025

Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear. It has become the worldwide standard of care for acute neonatal pain, but it doesnt seem to be helping in the long term. Read the original article.

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FDA Law Blog

FEBRUARY 5, 2024

Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. The Draft Guidance emphasizes that study team should not answer the questions based on observation or even on existing medical records. By Deborah L.

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FDA Law Blog

JANUARY 23, 2023

The COVID-19 pandemic temporarily halted many clinical trials and left an indelible mark on clinical trial recruitment. The challenges of the pandemic may have affected participation by underrepresented participants even more than other groups. by the end of 2023).

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PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2011 Aug;58(2):145-55. Cervical Spine Injuries are fortunately rare in children. this episode is all about learning when to suspect them, how to immobilize the C-spine properly, and which imaging test to choose.

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GeriPal

MARCH 16, 2023

How do you find time to write and also be doctors and academic professors? Revisions and working with editors Writing an Op Ed – how to start, what to write, where to send it TheOpEdProject as a resource for learning more We look forward to the books and op-eds our listeners will write! Welcome to the GeriPal podcast, Rosanne.

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GeriPal

JULY 7, 2022

And then one day when I was in my third year of medical school, I was in the gym and I hurt my back in a really horrific way. We discussed the nature of pain, what makes chronic pain different from acute pain, what’s the difference between proprioception, pain, and suffering, and so much more. Welcome back to the GeriPal podcast, Haider.

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Medical Xpress

JUNE 7, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. None of the participants who received the injections got HIV. That early success helped boost Gileads stock by 73% over the past year, The Wall Street Journal reported. "We What are the consequences?

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GeriPal

DECEMBER 1, 2023

And the two were sort of intermeshed even to the point in the eighties, the thought was all dementia is Alzheimer’s or it’s some medical illness or combination of other stuff that’s not about it. He’s been on several podcasts about this issue. Jason, welcome back to GeriPal. Eric: Wonderful. Jason: Oh, well.

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Medical Xpress

JUNE 8, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The research, published this week in Safety Science , collected data from 562 recreational surfers from 2020 to 2023. This study helps to quantify surfers impact on community safety.

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Medical Xpress

JUNE 23, 2025

Other factors including humidity, wind and peoples ages and medical conditions play a role in heat illness as well, Wood says. Officials warn of increased risks for the elderly, outdoor workers and those without AC. Your blood pressure may decrease." If there is any sweat on the skin, it dissipates and the skin becomes very dry, he says.

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FDA Law Blog

JUNE 9, 2021

As explained in CPG 440.100 and on FDA’s website , FDA adopted the “Unapproved Drug Initiative” (“UDI”) in 2006—later revised in 2011 —to remove unapproved drugs from the market using a risk-based approach both to ensure the safety and efficacy of all drug products on the market and the integrity of the drug approval process.

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PEMBlog

APRIL 4, 2025

So serious bacterial infection defined as any bacterial infection requiring medical intervention, but it may not invade sterile sites. Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. Unfortunately. It’s getting more common. Interesting.

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Physicians News Digest

APRIL 1, 2025

Trump has empowered the Elon Musk-led Department of Government Efficiency, which he established and named by executive order, to make deep cuts in federal budgets , halting some medical research and aid programs in addition to cutting spending on climate change, transgender health, and diversity, equity, and inclusion programs.

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