FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). If SCOTUS takes up this case, it could have significant and far-reaching implications across the healthcare fraud and abuse landscape. Background.

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FDA Law Blog

DECEMBER 12, 2023

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine.

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FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). Supporting information is critical to illustrate the specific points of regulatory misconduct.

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My Green Doctor

MAY 3, 2025

That’s why our Practice Management program includes a guided, meeting-by-meeting path for helping clinics transition to renewable energy and cut utility bills—without overwhelming staff or adding to your to-do list. The product manufacturers and vendors will need to be active partners as well.

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FDA Law Blog

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development. The latest iteration, version 5.0, released in April 2024, marks the first update since 2020.

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Imperial Center Family Medicine

MAY 26, 2025

Limiting these cholesterol-raising oils is just as important as utilizing healthier options in your cooking. How Cooking Oils Impact Cholesterol Before getting into specific oils, it helps to know a little about dietary fats and cholesterol. Cholesterol is a form of fat with a waxy consistency that is found in your blood.

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FDA Law Blog

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

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FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. See our previous coverage of such state laws here , here and here.) North Dakota.

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FDA Law Blog

DECEMBER 16, 2024

The final guidance appears not to make any meaningful changes that are actually likely to support or incentivize its increased utilization, which is disappointing, although not unsurprising. As we have previously discussed, the Third Party 510(k) Review Program is not widely used.

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FDA Law Blog

MAY 27, 2024

With her return to the firm, she can now utilize her recent in-house experience to help HPM’s diverse client base solve complex problems. She was an outstanding lawyer before, and her in-house experience will provide even greater breadth and depth of expertise to medical device manufacturers,” notes Jeffrey Gibbs, HPM Director.

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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GeriPal

MAY 5, 2022

Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice?

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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CDOCS

JUNE 30, 2021

Next, following manufacturer&rsquo;s instructions for use, CLEARFIL&trade; CERAMIC PRIMER PLUS (Kuraray Noritake) was applied to the intaglio of each restoration, followed by PANAVIA&trade; V5 Tooth Primer to each tooth prep, and lastly PANAVIA&trade; V5 Cement to the intaglio of each restoration prior to final seating.</span></p>

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FDA Law Blog

MARCH 27, 2023

Legacy FDA identification numbers refer to both National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers created using labeler codes previously assigned to device manufacturers by FDA. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” Emphasis added.)

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FDA Law Blog

NOVEMBER 7, 2023

Well, what FTC apparently did was review hundreds of patents in the Orange Book and utilize FDA’s regulatory processes. But there’s no telling what the implicated manufacturers will do, because again, it is legally unclear whether the listing of the device patents is actually anticompetitive. and published by FDA.”

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CDOCS

MAY 4, 2021

I utilized 2CC of the mineralized freeze-dried allograft, particle size 500um to 1000um. The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings. I chose to utilize a zirconia abutment and selected shade 20 used for midrange shades in the VITA shade guide, i.e. A2.

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FDA Law Blog

OCTOBER 14, 2021

Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer. 21 U.S.C. §

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FDA Law Blog

MAY 15, 2023

Manufacturers are responsible for determining that the common food is safe and has utility for its intended use prior to commercial distribution as animal food. At the federal level, the Center of Veterinary Medicine (CVM) of FDA regulates food for animals, including livestock and pets.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

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FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA has model recall communication templates available here that firms can utilize. Walsh — All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field.

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FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. For additional information on planning patient engagement, please see the CDRH’s Patient Science and Engagement Program. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance.

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FDA Law Blog

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

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FDA Law Blog

NOVEMBER 15, 2022

BLA for product licensed for further manufacturing use only. Note: the third-party charges a fee for its review. Not eligible. Not eligible. Not eligible. Exempt from User fee. Small Business Program. FDA’s Small Business Program reviews requests by medical device companies to be considered small businesses. of the FDA Guidance ).

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FDA Law Blog

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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FDA Law Blog

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.

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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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FDA Law Blog

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

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FDA Law Blog

MAY 11, 2023

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

These funds could be utilized for various purposes, including direct care, operational expenses, and facility maintenance or upgrades. These funds could be utilized for various purposes, including direct care, operational expenses, and facility maintenance or upgrades.

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FDA Law Blog

SEPTEMBER 5, 2023

Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. Registrants would have to create and maintain inventory and transaction records, file certain reports and maintain adequate security. Schedule III placement would loosen registration requirements for researchers.

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CDOCS

JULY 7, 2021

I planned to utilize the Biocopy Design Mode feature in Chairside software as the blueprint and basis for the final design albeit with modifications to enhance the outcome. The opposing arch and bite were optically impressed completing all the necessary information needed to design and manufacture the case.

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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

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. Manufacturers receive no benefits in exchange for the inflation rebates.

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