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). The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. Background.

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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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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. The North Dakota law includes three reporting requirements for drug manufacturers.

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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 ). By Véronique Li, Senior Medical Device Regulation Expert & Anne K.

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FDA Law Blog

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

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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. Looking for a tailored approach?

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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

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

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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Imperial Center Family Medicine

MAY 26, 2025

Limiting these cholesterol-raising oils is just as important as utilizing healthier options in your cooking. Partially Hydrogenated Oil To give processed foods a longer shelf life, manufacturers often add partially hydrogenated oil, a source of trans fats that are much worse for cholesterol levels than saturated fats.

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FDA Law Blog

SEPTEMBER 11, 2023

As a reminder, devices with preamendment status are those that were legally marketed in the US before May 28, 1976, have not been significantly changed since May 28, 1976, and for which a regulation requiring a premarket approval application has not been published.

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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

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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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

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. However, while AAFCO is receiving feedback on this first proposed list of products, applications for additional common foods are not accepted.

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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.

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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

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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GeriPal

MAY 5, 2022

Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. Five big manufacturers. Is that right?

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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. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers.

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FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry.

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Physician's Practice

JUNE 9, 2025

Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws.

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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

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.

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FDA Law Blog

NOVEMBER 15, 2022

BLA for product licensed for further manufacturing use only. To reduce the chances of inefficiencies with delivery and processing, we recommend utilizing eSTAR to submit your applications to FDA. Third-party review. Exempt from FDA user fee. Note: the third-party charges a fee for its review. Not eligible. Not eligible. Not eligible.

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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

OCTOBER 16, 2024

By leaving intact Bristol-Myers Squibb , notwithstanding the argument that Loper Bright nullifies it, the Court preserved an important avenue for generic drug manufacturers. We note, however, that this is unlikely to be the last affront to the skinny-label, which clearly remains a target for RLD sponsors.

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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

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.

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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

SEPTEMBER 5, 2023

Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. In addition, there was no consensus of experts opinion about the medical utility of cannabis treating specific recognized disorders.

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FDA Law Blog

NOVEMBER 16, 2021

In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs. Manufacturers covered by this provision will have to pay refunds for discarded amounts beginning 18 months after the drug is first covered under Part B, but no earlier than January 1, 2023.

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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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