FDA Law

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. For this last question, FDA explains that it anticipates the sponsor would charge the patient directly or would charge a payor if reimbursement were available, but clearly states that FDA has no authority in this arena.

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FDA Law

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Clinic Medical Provider Patients 52

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

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FDA Law

MAY 7, 2025

Regulatory Framework The AKS makes it a criminal felony to knowingly and willfully offer or pay any remuneration, directly or indirectly, to induce a person to order or refer patients for medical care that is reimbursable under a federal healthcare program (e.g., Medicare or Medicaid).

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GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. But individuals who have hearing loss, there’s several problems. How to screen for hearing loss.

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IT Screening Hospital Clinic 102

FDA Law

JANUARY 26, 2022

FDA alleged that because the TV ads contained representations or suggestions relating to Emgality’s indication for use, they were required to include risk information as well adequate provision for the dissemination of the PI or a brief summary as required by 21 C.F.R.

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IT Education Utilities Patient-Centered 40

FDA Law

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability). Customer Support Help line).

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Specialization Clinic Provider IT 40

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations.

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FDA Law

OCTOBER 16, 2024

There, as we explained back in July , Novartis argued that FDA’s approval of a generic ENTRESTO with indication information modified rather than simply omitted “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.” The Court noted that the D.C.

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Manufacturing Patients IT Hospital 98

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). PCR, nor will they perform as well in patients with a low viral load.

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Screening Manufacturing Healthcare IT 98

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

To incentivize donations to these hospitals, the bill suggests creating a tax credit for individuals and entities to offset their state income tax liability. To incentivize donations to these hospitals, the bill suggests creating a tax credit for individuals and entities to offset their state income tax liability.

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FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. The concerns raised by PERA are not limited to these industries, however. HPM is currently representing AMP in unrelated litigation.)

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Manufacturing Clinic IT Vaccination 64

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. Then fast forward a year.

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Illness IT Patient-Centered Patients 107

FDA Law

JANUARY 8, 2023

Doctor-Patient Relationship. Also of great importance is the Act’s authorizing state-licensed physicians to advise patients or their legal guardians of the potential harms and benefits of cannabis derivatives as a medical treatment. DEA then has 30 days after receiving supplemental information to issue or deny a registration.

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Medical Manufacturing Electronics Provider 64

FDA Law

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Emphasis added.)

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Medical Diagnosis Healthcare Clinic 53

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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Manufacturing Vaccination Government Diagnosis 59

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. A recent state law failure-to-warn case in the SDNY makes that very point.

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

MARCH 24, 2022

Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. Ideally, there’ll be a place in the chart that actually captures the name of that person and their contact information.

Illness 72

Illness IT Healthcare Patient-Centered 72

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. The Bureau of Clinical Laboratories at ADPH is also providing testing but should be prioritized for patients that are underinsured or uninsured.

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Patient-Centered Provider Manufacturing Screening 130

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. So it’s hard to know about individual practice when I think of geriatrics or geriatric nursing because a lot of the solutions are really broad scale public health initiatives are needed, don’t you think?

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Healthcare IT Education Hospital 129

FDA Law

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs). 8126 with a lower MFP.

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Manufacturing Insurance Government Patients 52

GeriPal

OCTOBER 31, 2024

And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. That trauma may have been caring for patients who were sicker from respiratory virus than I often have ever seen. Let’s say for nursing home patients, older. All good ones.

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Vaccination IT Patient-Centered Patients 127

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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Manufacturing Supply Chain Patient-Centered Utilities 98