Plum Health

AUGUST 30, 2024

Managing diabetes—especially as you get older—can be challenging physically, emotionally, and financially. Before diving into the nitty-gritty of cost, let's briefly talk about what Ozempic is and why it's become such a popular choice for managing Type 2 diabetes. Ozempic injection pen.

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Primary Care Insurance Diabetes Manufacturing 52

FDA Law Blog

NOVEMBER 29, 2023

Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management. See our prior blog post on the topic here.

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The Medical Futurist

JUNE 21, 2025

It will break language barriers These M-LLMs will easily facilitate communication between healthcare providers and patients who speak different languages, translating between various languages in real time. The latest – and perhaps biggest – hit was the announcement of ChatGPT-4o from OpenAI. ” Patient : “Es un 8.”

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FDA Law Blog

MARCH 6, 2023

Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). Keen observers may have noticed that in the most recent semiannual regulatory agenda , neither the Quality System Regulation nor the Quality Management System Regulation is referenced.

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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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Manufacturing Provider Medical IT 98

My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. Organizations such as EyeSustain and My Green Doctor are educating clinicians and practice managers on ways to reduce medical waste and are promoting research on this topic. Reducing waste can save money for practices and operating rooms, and benefit the environment.

Medical 52

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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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Specialization Provider Medical Manufacturing 105

Minnesota Academy of Family Physicians

MARCH 27, 2025

As we move into the tenth week of the legislative session, Minnesota Academy of Family Physicians (MAFP) lobbyist Megan Verdeja breaks down what’s happening at the Minnesota State Capitol and provides an update on health care bills. The bill was passed by a voice vote and was sent to the Tax Committee. Read a summary of S.F.

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FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

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FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections.

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Management Manufacturing Specialization IT 52

FDA Law Blog

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.”

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FDA Law Blog

FEBRUARY 13, 2025

Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

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Manufacturing Management Specialization Provider 71

Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Nonetheless, actively cultivating specialized cholesterol-absorbing bacteria provides another route for reducing high blood cholesterol. Specific strains and enzymatic factors influence efficiency.

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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.

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Manufacturing Electronics Provider Management 64

FDA Law Blog

FEBRUARY 7, 2023

Part 807), establishing a quality management system (QMS) (21 C.F.R. For PMA devices, the marketing application contains quality system and manufacturing information, so getting started on the quality system in parallel to device development is important for a timely submission. Part 814), and for conducting clinical trials (21 C.F.R.

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Manufacturing Medical Engineering IT 98

My Green Doctor

MAY 3, 2025

This financial predictability allows for better budgeting and resource allocation.​ – Reduced Operational Costs : Implementing energy-efficient technologies, such as LED lighting and automated energy management systems, can decrease energy consumption by up to 30%, leading to further cost reductions. ​

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Healthcare Healthcare Professional Consulting Management 52

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.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections.

Management 40

Management Manufacturing Specialization IT 40

FDA Law Blog

NOVEMBER 20, 2023

The Agency wants to see functional, effective cultures of quality, and expects that C-suites will provide support to quality units. Quality agreements between manufacturers and third-party suppliers are on FDA’s radar, and the Agency has shown a willingness to delay approvals in the face of quality concerns.

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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

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. Trusting suppliers is still fundamental to any drug or device manufacturer. By John W.M. Dialogue is also key.

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FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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FDA Law Blog

OCTOBER 31, 2022

It seems that FDA may have validated that, even with an Excellence Appraisal above and beyond standard compliance with good manufacturing practices, there is a need for pre-market review for Class 2 devices. We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. Key Findings at 12.

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FDA Law Blog

SEPTEMBER 7, 2022

Number of Manufacturing Sites and Registered Products. The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537 NDAs and 315 BLAs. Import Alerts and Recalls.

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FDA Law Blog

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

Manufacturing 52

Manufacturing Insurance Patients IT 52

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.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law Blog

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

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FDA Law Blog

MAY 27, 2024

Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills. Ellison, Managing Director at HPM. Having worked with Jennifer for six years previously, I am truly excited to have her return.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Part 1, posted May 3rd, explains the purpose, background, and scope of DEA cyclic and on-site inspections.

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FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Part 1, posted May 3rd, explains the purpose, background, and scope of DEA cyclic and on-site inspections.

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FDA Law Blog

JUNE 5, 2025

The Office of Management, which was eliminated in the April 1 RIF, was responsible for processing these requests, and generally did so within 60 days of receipt. We note that the webpage for the Office of Management is still functional, but has not been updated since January 2024.)

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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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IT Patient-Centered Patients Clinic 121

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review.

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