PEMBlog

JUNE 14, 2023

Government. 2019 Jul 22;20(5):690-695. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what we should consider when boarding children in the ED for mental health reasons. Pediatrics March 2023; 151 (3): e2022057383. 10.1542/peds.2022-057383 West J Emerg Med.

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FDA Law Blog

AUGUST 29, 2021

The federal government does its own version of rebranding with each change in administration. The memorandum cites the 2019 Supreme Court decision, Kisor v. Walsh & JP Ellison — Companies often use rebranding to reposition and refocus their business. Wilkie , 139 S.

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FDA Law Blog

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. By Faraz Siddiqui & Alan M. 52494 (Nov.

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FDA Law Blog

JANUARY 31, 2022

attorneys’ offices since 2019, the Complaint seeks monetary and permanent injunctive relief ( see 21 U.S.C. §§ 832(f)(1) and 882(a)). Specifically, the Government filed the Complaint for a permanent injunction, and then moved for a preliminary injunction seeking an order to immediately stop defendants from handling and dispensing controls.

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FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. 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. Background.

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FDA Law Blog

SEPTEMBER 8, 2021

Under the Memorandum of Understanding signed in March 2019, FDA will oversee cell collection, growth, and differentiation of cells, and help coordinate transfer of oversight to FSIS at the cell harvest stage. FSIS requests input on a range of issues, including: Should the names of cultured products differ from those of slaughtered products?

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FDA Law Blog

APRIL 20, 2022

FDA approved Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adult patients in November 2018 with orphan drug exclusivity and subsequently approved a second amifampridine product, Ruzurgi, in May 2019 for the treatment of pediatric patients with LEMS. Becerra got a lot of attention. Britney Jean Spears.

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BMJ

JULY 17, 2020

Many Chinese expressed their disapproval of the many untrusted sources of information online while demonstrating a high level of trust towards the central government. Psychological health during the coronavirus disease 2019 pandemic outbreak. National involvement is also needed to facilitate these efforts.

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FDA Law Blog

FEBRUARY 2, 2023

While these changes to the IND and the biosimilarity provisions represent real changes to the words governing FDA’s authority under the FD&C Act, we think it is worth asking just how measurable and immediate an impact they will have on day-to-day decision-making of the FDA and its review staff.

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FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

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FDA Law Blog

APRIL 19, 2021

District Court, which sided with Genus in December 2019. The judges also said that changes to the language of the governing Federal Food, Drug, and Cosmetic Act over the last couple of decades did not abrogate the clear statutory definitions. Two judges on the D.C. Genus challenged the designation of barium sulfate as a drug in U.S.

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FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

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Health One Family Medicine

APRIL 30, 2021

The laws governing the skincare and cosmetics industry are very limited. Contaminated Talc In 2019, the FDA advised consumers to avoid using certain cosmetic products because they tested positive for asbestos. You will be surprised to know that some known cancer-causing ingredients are allowed in beauty products.

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FDA Law Blog

MARCH 1, 2023

By way of background, FDA first proposed using a QMM rating in its 2019 Report on Drug Shortages and Potential Solutions. By Holly N. The lessons learned were also discussed during a November 2022 workshop hosted by the FDA. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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FDA Law Blog

FEBRUARY 5, 2023

Finally, the court found that legislative history did not necessarily support the government’s view—the most relevant language did not end up in the final statute, and that omission could have supported either party. HRSA argued that it unambiguously did, and the companies sued. Six district courts presided over these decisions.

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FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36 Million to Settle Claims of Controlled Substance Act Violations (June 8, 2022). 4, 2022).

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FDA Law Blog

JANUARY 6, 2022

S&G Labs alleged during the litigation that they are paid on a “per test” basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct “self-pay” by some individuals. His job was governed by an employment contract that contained both salary provisions and restrictive covenants.

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FDA Law Blog

JANUARY 6, 2022

S&G Labs alleged during the litigation that they are paid on a “per test” basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct “self-pay” by some individuals. His job was governed by an employment contract that contained both salary provisions and restrictive covenants.

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Tiny Physician

DECEMBER 11, 2021

The PG doctors strike has entered its 12th day at the time of publishing this article and it has badly affected the patient care at the Government Medical Colleges (GMCs). KMPGA put forward the following demands in front of the state government: 1. They are forced to skip their meals, let alone their household chores.

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The Clinical Problem Solvers

OCTOBER 11, 2021

In contrast, de jure segregation refers to the involvement of federal, state, and local governments in creating, structuring, designing, reinforcing, and perpetuating segregation. This reality of de jure segregation helps us understand that we have an obligation to remedy this constitutional violation.

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GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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FDA Law Blog

FEBRUARY 9, 2022

Houck — The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure to identify and resolve red flags. Holiday CVS, 77 Fed. at 62,341; see Jones Total Healthcare Pharmacy, L.L.C.

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GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. 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. Cochrane Database of Systematic Reviews Review.

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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

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Sheldon, v.

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GeriPal

APRIL 18, 2024

We discuss, among other things: Findings that in several studies AI was rated by patients as more empathetic than human clinicians (not less, that isn’t a typo). Turns my concern about lack of empathy from AI on its head – the AI may be more empathetic than clinicians, not less. ” Eric: What was it called again, Wachter’s World?

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Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. Contrary to our beliefs, the second wave came and exposed all the weaknesses of our health system. Dipankar et.

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Common Sense Family Doctor

FEBRUARY 21, 2025

Oh, and the CDC's National Immunization Survey has been canceled by the so-called Department of Government Efficiency, even if the Epidemic Intelligence Service seems to have received a temporary reprieve.) to a massive resurgence in 2019, presaged by smaller blips in the prior years? this is it. over the past 30 years.

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Physician's Weekly

JUNE 12, 2025

Other experts told PolitiFact that the actual numbers could be higher than what the federal government reports, although not as high as Paragon’s estimate. It is funded through a mix of federal and state money and is administered by states under federal government rules. How High Is the Medicaid Improper Payment Rate?

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Physician's Weekly

JUNE 26, 2025

A Failed Compensation Program Vaccine advocates and skeptics agree that the government program established to compensate people injured by vaccines or other public health measures during emergencies — the Countermeasures Injury Compensation Program — has miserably failed those with covid vaccine-related injuries. Kennedy Jr. The current U.S.

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The Clinical Problem Solvers

MAY 2, 2023

Hayat discusses the five major waves of migration in the last fifty years, resulting from the Soviet-Afghan War, the Afghan Civil War, the Fall of the Taliban, August 2021 US and western forces departure, and how he grew up during the 1990s right after the collapse of the government.

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FDA Law Blog

OCTOBER 14, 2022

The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. We’re still doing a lot of work on it.

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FDA Law Blog

MAY 8, 2025

Government Accountability Office (GAO) reported in 2019, that FDAs practice of preannouncing foreign inspections up to 12 weeks in advance may give manufacturers the opportunity to fix problems. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made. In 2024, Hyman, Phelps & McNamara, P.C.

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Common Sense Family Doctor

NOVEMBER 22, 2024

State and local governments decide what vaccines to require. See Samoa, 2019.) It isn't because he isn't a health professional or doesn't have any experience running an organization of this size (or even the smaller size it might become once the inefficiently two-headed Department of Government Efficiency goes after it).

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GeriPal

APRIL 17, 2025

What a Wonderful World could be sung in irony at this moment. I hope we all take it literally, with the hope this podcast ends with. Alex Smith ** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here. Transcript Eric 00:00 Welcome to the GeriPal Podcast. It is a terrific book. Alex 02:07 Yeah, I love it.

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FDA Law Blog

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Last Thursday, the U.S. The actual policy proposals read like a wish list. Below, we summarize the key proposals of the HHS plan.

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Physicians News Digest

APRIL 1, 2025

And as one of the first actions of his second term, Trump fired 17 independent inspectors general responsible for rooting out fraud and waste in government. “It For example, Trump granted a commutation to Philip Esformes, a Florida health care executive convicted in 2019 of a $1.3 Taken back a lot of that money,” Trump said. “We

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