FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. 21 U.S.C. §

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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

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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FDA Law Blog

OCTOBER 2, 2024

As both these categories of changes are currently permitted via a PMA supplement, and the goal of FDORA is to provide an alternative to the need for such supplements, we would expect major changes and modifications to intended use to be permissible via a PCCP as long as the device remains safe and effective without any change.

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FDA Law Blog

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

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FDA Law Blog

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. Some products may move with high velocity to patient use. A December 2021 warning letter to Medtronic, Inc.

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

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GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Tasce: Yes.

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Physician's Weekly

JUNE 19, 2025

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. But a lot of patients say, like Bob would: My doctors and I had already DONE all this checking. Dan: We see it all the time.

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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.

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Common Sense Family Doctor

FEBRUARY 15, 2025

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The ad states that patients may pay as little as $5 per dose, 4 times per year.… Who could blame a patient for believing the drug doesn’t cost much.

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FDA Law Blog

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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FDA Law Blog

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. Just like it was over a decade ago in Pliva v. FDA, for years, has been concerned with overwarning.

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FDA Law Blog

JANUARY 11, 2022

Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….” The Federal Circuit twice reversed the District Court decision at issue in GSK v.

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FDA Law Blog

JANUARY 11, 2022

Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….” The Federal Circuit twice reversed the District Court decision at issue in GSK v.

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FDA Law Blog

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

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FDA Law Blog

OCTOBER 14, 2022

It was January 31, 2020 when the Secretary of the Department of Health and Human Services (HHS) first declared the 2019 Novel Coronavirus (2019-nCoV) outbreak a public health emergency (PHE), pursuant to Section 319 of the Public Health Service Act (see here ). Before we talk about the future, let’s briefly review the history.

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FDA Law Blog

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. By Dara Katcher Levy & Sara W. Koblitz & Jeffrey N. it is illegal to import. 70,796, 70,800 (Dec. consumers.

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FDA Law Blog

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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