FDA Law Blog

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

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FDA Law Blog

SEPTEMBER 26, 2024

Manufacturers can expect increased interaction with the review team and prioritized review of the marketing submission.” The Breakthrough program started in 2015. The reality, however, is quite different. Since that time, CDRH has granted 921 Breakthrough devices, and CBER has granted 12.

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FDA Law Blog

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. The warning letter is long and covers many issues associated with the management of risks associated with malfunctions and complying with the complex web of regulations potentially applicable when malfunctions occur.

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FDA Law Blog

FEBRUARY 4, 2022

The Proposed Rule will not apply to drug manufacturers: FDA stated that it “considers the activities of a manufacturer, as defined at section 581(10) of the FD&C Act, when distributing its own drug, as excluded from the definition of wholesale distribution and not subject to the requirements that apply to wholesale distributors.”

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FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

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FDA Law Blog

JANUARY 26, 2022

This content is likely one of the reasons for FDA’s withdrawal of the Draft Guidance in 2015 – the same year that FDA suffered one of the most significant blows regarding First Amendment protections for pharmaceutical manufacturer speech. Where FDA does not have jurisdiction, the agency may nevertheless take appropriate action (e.g.,

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FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. FDA began an initial VMSR pilot program in 2015. The draft guidance sets forth a process for doing so.

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FDA Law Blog

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.” That’s precisely what FDA did here when it approved the modified label.

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FDA Law Blog

AUGUST 21, 2023

Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false. But we digress.

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GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin).

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FDA Law Blog

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

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GeriPal

DECEMBER 7, 2023

And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. Elders Climate Action, and let me just tell you a little bit about who we are, was created in 2014 as the project of a 501(c)(3), Elders Action Network.

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FDA Law Blog

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

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