Plum Health

AUGUST 30, 2024

Everything You Need to Know About Costs and Coverage Patient is inquiring about healthcare. Why Plum Health Direct Primary Care Is Your Best Option for Affordable Ozempic and Wegovy At Plum Health Direct Primary Care, we provide an innovative solution to the high cost of medications like Ozempic and Wegovy.

Primary Care 52

Primary Care Insurance Diabetes Manufacturing 52

FDA Law Blog

MAY 29, 2025

Therefore, it seems reasonable that AI models could be trained on the data, provide useful insights to reviewers, and speed up review times. Applying AI models to review large amounts of data from multiple manufacturers could help FDA identify early signals related to product quality and patient safety.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

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., use in education, construction, art, and jewelry).

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

Provider 59

Provider Medical Manufacturing Consulting 59

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.

Manufacturing 98

Manufacturing Provider Medical IT 98

My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. 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. tons in the United Kingdom each year. 3 “Each U.S.

Medical 52

Medical Supply Chain Hospital Healthcare 52

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.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change. 150,000).”

Provider 64

Provider Manufacturing IT Medical 64

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., use in education, construction, art, and jewelry).

Medical 75

Medical Manufacturing Healthcare Government 75

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. It applies whether the software is the entire device (i.e.,

Specialization 105

Specialization Provider Medical Manufacturing 105

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 ).

Patients 52

Patients Clinic Medical Patient-Centered 52

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> <p>Drs. </p>

Manufacturing 52

Manufacturing Utilities Patients IT 52

FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

JUNE 2, 2025

Those in the lab industry and the physicians and patients who rely upon LDTs are sure to be breathing a well-deserved sigh of relief over this development. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

IT 64

IT Manufacturing Government Clinic 64

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. The breadth of services provided by modern day medicine is profound. Dilating and anesthetic eye drops are routinely offered to patients in most ophthalmology clinics.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

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.

Manufacturing 52

Manufacturing Insurance Patients IT 52

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.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

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.

Electronics 59

Electronics Manufacturing Provider Medical 59

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. These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

Manufacturing 72

Manufacturing Government Healthcare Management 72

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. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

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.

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law Blog

JUNE 27, 2023

James’s status as a 15-year champion for bringing patient voices to the table with FDA and industry decision-makers was also considered. James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development.

Management 81

Management Manufacturing Patients Provider 81

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).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. &

Patient-Centered 52

Patient-Centered Patients Manufacturing Clinic 52

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.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

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?

Manufacturing 45

Manufacturing Provider Consulting IT 45

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.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

JUNE 28, 2021

If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. For the purposes of assessing the annual opiate product registration fee, a “unit” means “the individual dosage form of the particular drug product that is prescribed to the patient. 151.066, Subd.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law Blog

DECEMBER 15, 2024

In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. As you review these questions and answers, nothing that CBER provides in this guidance is new. Questions and Answers Guidance (see previous coverage here ).

Manufacturing 52

Manufacturing Engineering Patient-Centered Provider 52

FDA Law Blog

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

FEBRUARY 15, 2023

By amending and repealing certain parts of the regulation, FDA believes that compliance to standards adequately protect public health and provide a reasonable assurance of safety and effectiveness when appropriately used by trained personnel. Manufacturers, therefore, have ample time to familiarize themselves with the changes.

Manufacturing 52

Manufacturing Electronics Medical Clinic 52

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.

Manufacturing 52

Manufacturing IT Provider Patients 52

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.

IT 52

IT Manufacturing Utilities Complication 52

FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

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. This proposed rule is a long-time coming. After Congress failed to enact VALID in December 2022, as part of user fee reauthorization, CDRH declared its intention to promulgate LDT regulations.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. The following example is provided in the preamble: If Part B paid a total of $1.5 million).

Manufacturing 52

Manufacturing Utilities Government Provider 52