FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state.

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Medical Xpress

MAY 1, 2023

Mejias had been taking a drug to treat a rare skin disease for about two years when its manufacturer effectively cut off his supply.

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The Medical Futurist

JUNE 21, 2025

To diagnose and treat a patient, a healthcare professional listens to the patient, reads their health files, looks at medical images and interprets laboratory results. ” M-LLM (Translating for Patient): “¿Puede señalar dónde le duele? ” M-LLM (Translating for Patient): “¿Puede señalar dónde le duele?”

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Plum Health

AUGUST 30, 2024

Everything You Need to Know About Costs and Coverage Patient is inquiring about healthcare. For example, I had a patient who was able to get her Ozempic at a fraction of the cost through Novo Nordisk’s assistance program after her insurance only partially covered the medication. Ozempic injection pen.

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FDA Law Blog

OCTOBER 4, 2022

By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. This means there needs to be a better way to understand the outcomes of urgent issues. This is unproductive.

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FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device.

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FDA Law Blog

MAY 29, 2025

Another area for which AI models may be suited in the medical device space would be post-market data, such as Medical Device Reports, where the data submitted is in a more standardized format from manufacturer to manufacturer. FDA has been working for years to understand the complexity of AI and how to ensure it functions as intended.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., This guidance document is still in effect today.

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CDOCS

AUGUST 11, 2021

</span></p> <p><span style="font-size:14px;">This patient presented with a chief complaint of his poorly matching crown on tooth #9. .</span></p> This crown has been in service for 10 years, but now the patient would like to replace it for his daughters upcoming wedding (figure 1).

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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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FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

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FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. Pfizer, Inc. July 25, 2022. Background.

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My Green Doctor

MAY 3, 2025

Innovative surgeries, novel pharmaceuticals, and state of the art technology are just a few of the driving forces that have aided the delivery of exceptional care to patients across all specialties. Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. 3 “Each U.S.

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CDOCS

MAY 11, 2019

& Patient presents as an 80 year old woman who was wearing an ill fitting partial for awhile and was losing weight because eating was very difficult. & jpg]</p> <p>So, once the bridge came in from the lab, we had the patient come in. & Here is how she presented:</p> <p>[image:Untitled_2_001.jpg]</p>

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., This guidance document is still in effect today.

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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CDOCS

JANUARY 12, 2021

It saves dentists time and money while attracting patients and adding valuable services.</p> They currently leverage inLab design software and SprintRay to create as many same-day opportunities for their patients as possible. <p>CEREC design tools are widely used in many dental practices.</p> </p>

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My Green Doctor

MAY 3, 2025

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Dilating and anesthetic eye drops are routinely offered to patients in most ophthalmology clinics. Now, more than ever, they must also become champions of planetary health.

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FDA Law Blog

MAY 31, 2021

PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance. Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs such as co-pays and deductibles. In December 2020, CMS published a final rule making several changes to the MDRP regulations.

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FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. This provision became effective as of March 29, 2023.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

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FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP.

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FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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CDOCS

JUNE 23, 2021

& A core file is then returned to design and manufacture the bridge.& & A core file is then returned to design and manufacture the bridge.& & The patient had an Axeos CBCT Scan and an optical scan with CEREC 5.1.2 In this case, however, the decision was made to have the patient return for new imaging.

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FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Avdel amicus brief).

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. One unit equals one tablet, capsule, patch, syringe, milliliter, or gram.” 151.066, Subd.

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FDA Law Blog

OCTOBER 6, 2021

By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. Code Ann. §

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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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FDA Law Blog

NOVEMBER 7, 2021

We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement. Last week, the U.S.

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FDA Law Blog

JUNE 22, 2023

CDRH may express concerns that patients will not understand when the test is appropriate for them, that they will misinterpret or overly rely on results, or that they will forego or delay visits to a doctor. By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. lay users). seeking treatment).

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FDA Law Blog

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. The proposed rule has a 60-day comment period for stakeholders. This proposed rule is a long-time coming.

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