FDA Law Blog

OCTOBER 25, 2021

The regulatory uncertainty has ill?befitted In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. FDA says inspections may be necessary if a device has “critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device.”

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CDOCS

APRIL 14, 2021

& But, I don&rsquo;t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> & & First, you&rsquo;re getting a CEREC system for single unit posteriors.& & Yes, the Primescan is amazing.&

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FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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FDA Law Blog

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

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FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

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The Health Policy Exchange

MAY 20, 2013

Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. In the meantime, lobbyists working for the drug manufacturers successfully blocked efforts by Medicare administrators to stop paying for the higher (harmful) doses. Approval from the U.S.

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GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We’re going to be talking about new research in psilocybin in serious illness. This is Eric Widera. Alex 00:03 This is Alex Smith. Thats a lot of S s.

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FDA Law Blog

NOVEMBER 22, 2022

Gaulkin — At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss.

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GeriPal

MARCH 24, 2022

Then listen to these prior podcasts with Sean Morrison and Rebecca Sudore about this issue, and we recently discussed differences between Advance Care Planning and Serious Illness Communication with Juliet Jacobsen and Rachelle Bernacki. . Where does POLST fit in with this debate? Among other topics. We can work it out! This is Eric Widera.

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FDA Law Blog

MAY 15, 2025

He also specifically mentioned rare diseases here , in addition to his example of late-stage illnesses. He delivered sharp words on tobacco and e-cigarette imports, warning that foreign manufacturers are gaming our porous border by importing products that would be illegal in their own countries.

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FDA Law Blog

JUNE 4, 2025

This Assessment does not itself prescribe specific remedies for the ills it diagnoses; those are supposedly coming in the future Strategy document. complex public health issues within 100(!) In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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Alabama Academy of Family Physicians

FEBRUARY 20, 2025

In 1996, a variant of H5N1 was documented overseas that resulted in a severe illness in birds and was designated as highly pathogenic avian influenza (HPAI). Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. However, the 68 human cases in the U.S.

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Adventures of a Sick Doctor

JUNE 14, 2025

Hot dog manufacturers. I could definitely have milked the social media market and got myself a squillion followers, and then sold them tiny packets of curcumin to cure all their ills. I just can’t help it. It has been dawning on me over the past 11 years (slow learner) that I may be approaching the cancer patient lark the wrong way.

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FDA Law Blog

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. When this author read the January Notice, it seemed like an ill-thought-out proposal.

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GeriPal

OCTOBER 31, 2024

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question. Is that right?

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FDA Law Blog

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C.

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FDA Law Blog

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. More Steps Ahead As the SIP sponsor, Florida will be responsible for implementing the program.

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