FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

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FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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FDA Law Blog

FEBRUARY 21, 2024

1842 ) (Innovative FEED Act), introduced in 2023, would amend the FDC Act to provide CVM with the required authority. By Riëtte van Laack — On Feb. 2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). That remains to be seen. 6687 and S.

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. FDA), and to generate data in a format that would streamline FDAs review.

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FDA Law Blog

NOVEMBER 7, 2024

According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame. If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA.

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FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. For example, in an October 13, 2023 WL to ReNovo, Inc.,

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Family Physicians of Greeley

MAY 17, 2023

If you struggle with sleep difficulties, consider implementing relaxation techniques or consulting with a healthcare professional. Surround yourself with supportive and positive individuals who uplift you and provide a sense of belonging. Maintaining good mental health is essential for our overall well-being.

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FDA Law Blog

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

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FDA Law Blog

AUGUST 21, 2023

16, 2023 ( DOJ Press Release ). These settlements provide powerful reminders for “regulated sellers” of PSE, ephedrine and phenylpropanolamine. Regulated sellers must train employees on SCLP sales requirement content developed by DEA and listed on the DEA website provided at the Diversion Control Division Retail Training Page.

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FDA Law Blog

FEBRUARY 1, 2022

To that end, FDA announced that it would take the public input it has received and form a working group to address efforts to “modernize the Orange Book, improve transparency, and provide useful information to regulated industry and the public” by…considering the comments that it has supposed to have been considering all along.

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FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., By Philip Won & McKenzie E.

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FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. If a submitter believes that certain testing described in the draft guidance does not apply to their device, they should provide a rationale in the 510(k) submission.

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FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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FDA Law Blog

APRIL 23, 2023

The Draft Guidance states that sponsors should consult with the review division early in development about whether an externally controlled trial is reasonable, and they should submit their SAP with the protocol before initiating enrollment. This is potentially discouraging to sponsors of drugs intended for rare and serious diseases.

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PEMBlog

SEPTEMBER 6, 2023

They carry existing diagnoses and are followed by outpatient mental health providers. Attention to any toxidromes, any abnormal vital signs or mental status, eye findings, and neurologic examination provide the greatest help in narrowing the differential diagnosis. Hosp Pediatr (2023) 13 (1): 66–71 J Emerg Med.

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FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. By Larry K. 823(g)(1).

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Physician's Weekly

JUNE 19, 2025

On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. “We step into places where other providers may not, and geriatrics is a prime example of that.” “Hello. How are you feeling?”

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Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. Most sore throats are common cases, so it can be hard to know when to seek urgent care or when to just rest at home. Swollen neck Neck swelling may suggest an infection spreading into deeper tissues.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? He left without it.

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GeriPal

JANUARY 16, 2025

We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions. Alex 02:21 For Eric 02:21 For unrepresented older adults. But before we go into that topic, Tim, I think you have a song request. Tim 02:29 Yeah, it’s such an honor to make a song request. Can you guys do that one?

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes it rewarding? those experiencing homelessness).

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FDA Law Blog

JUNE 26, 2023

The Comprehensive Methamphetamine Control Act of 1996 (“MCA”) amended the Controlled Substances Act (“CSA”) by providing for the Attorney General to publish a Special Surveillance List of chemicals and other “laboratory supplies” used in the clandestine manufacture of controlled substances. 39,479, (June 16, 2023). 21 U.S.C. §

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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Updated 2023 Jul 17]. Take it away, Emily.

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FDA Law Blog

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

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FDA Law Blog

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. DAP Goal Rationales The sponsor must also provide a rationale for the study’s proposed enrollment goals, including information and analysis to explain how these goals were determined.

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PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Clin Toxicol (Phila) 2023; 61:453. Updated February 26, 2024. Accessed January 13, 2025. link] Hogge RL, Spiller HA, Kistamgari S, et al. Intelligencer.

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FDA Law Blog

AUGUST 21, 2023

Koblitz & Deborah L. Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” More than a few have taken far longer—literally decades.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate. What similarities do you notice?

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GeriPal

SEPTEMBER 5, 2024

Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. But before we go into all of that, I think, Bill, you have a song request for Alex. Bill 01:52 I do. Bill 01:53 Alex asked me for a song that was resonating in my head at the time, and it would be Guy Clark’s song, T he Cape. I’ll make sure.

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FDA Law Blog

JUNE 10, 2025

The agency revised the list in October 2023 when it added twenty-eight chemicals, removed two List I chemicals automatically included as a laboratory supply and added “tableting machines, including punches and dies.” One commenter, without providing details, asserted that the chemical may have uses in the medical field. 21 U.S.C. §

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FDA Law Blog

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. As the report explains: This report provides a vision for harnessing research and development (R&D) advances in biotechnology and biomanufacturing to build supply chain resilience. bioeconomy.”

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Physicians News Digest

MAY 12, 2025

Wade in 2022, abortion providers like her had been expecting prosecution or another kind of legal challenge from states with abortion bans, she said. “It It was unclear when those tests would come, and would it be against an individual provider or a practice or organization?” By Rosemary Westwood, WWNO When the news broke on Jan.

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PEMBlog

APRIL 4, 2025

And so I do encourage you to be familiar with some of the information provided by the CDC as long as it’s still online. So as of the 2023-24 school year, about 3.3% 2023 translates to about 80,000 kids in the United States, and vaccination coverage varies across states. So in the 2023-24 school year. Unfortunately.

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Physician's Weekly

JUNE 13, 2025

Also, the bill would curtail taxes that nearly every state levies on providers to help draw down billions in additional federal money, which generally leads to more money for hospitals. House Republicans passed the bill in late May, and it now awaits Senate consideration. That’s closer to 50% now, he said.

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