FDA Law

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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Management Manufacturing Medical IT 115

FDA Law

MAY 6, 2024

For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions. Manufacturers are required to design, develop, and provide a “reasonable assurance” that both the cyber device and related systems (e.g., update servers, network connections, cloud, etc.)

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Medical Manufacturing Provider Management 105

FDA Law

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” The final guidance includes several changes that are summarized below.

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Manufacturing Provider Management IT 105

FDA Law

JANUARY 16, 2025

While HPM prides itself on being the largest dedicated FDA law firm in the United States, it is small by design, so it is the quality of each of these individuals and what they contribute to the firm that is most exciting, said HPM managing Director J.P. Richardson has been promoted to Director.

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IT Manufacturing Individual Management 59

FDA Law

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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Manufacturing Management Medical Provider 105

FDA Law

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

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

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. Granted COVID has impacted regular DEA inspection schedules for most local DEA offices, but that is likely to change in the coming months.

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Management Manufacturing Specialization IT 52

The Medical Futurist

JUNE 21, 2025

The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work. The latest – and perhaps biggest – hit was the announcement of ChatGPT-4o from OpenAI. Just as we’ve seen how live translation works with ChatGPT-4o.

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Healthcare Healthcare Professional Electronics Medical 53

FDA Law

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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Management Manufacturing Supply Chain Provider 45

My Green Doctor

MAY 3, 2025

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. Single use has become the custom for most clinicians and managers, just as disposable products have become prevalent across the medical supply chain.

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Medical Supply Chain Hospital Healthcare 52

FDA Law

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

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

FDA Law

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

Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Restoring a flourishing and diverse gut microbiome becomes essential through dietary improvements, lifestyle changes, targeted supplements, and stress management approaches. Thus, cholesterol absorption and blood levels commonly spike.

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Family Medicine DO Screening Specialization 52

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. ​ The use of medications in U.S.

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Healthcare Healthcare Professional Consulting Management 52

FDA Law

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. Notably, Part 820 will look different.

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Manufacturing Management Medical IT 59

Minnesota Academy of Family Physicians

MARCH 27, 2025

Schools are seeing increased concerns related to managing acute and chronic health conditions, mental health issues and health fragility. The Minnesota Council of Health Plans (MCHP) raised concerns, as the bill enacts new regulations on health plans, and they contend they have little control over pricing set by drug manufacturers.

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Family Physician Insurance Finance Individual 52

Evergreen Family Medicine

MAY 2, 2025

Whether officer versus enlisted man, manufacturer or service industry versus governmental oversight agency, or physician versus health care administrator, the distrust and friction are instinctive. Rather, it crudely illustrates the distance between healthcare workers on the front line and healthcare management. In Part II, I wi

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Manufacturing Healthcare Management IT 40

FDA Law

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

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP.

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Manufacturing Electronics Provider Management 64

FDA Law

MARCH 3, 2024

Office of Management and Budget (OMB) can also specify other equipment or services to be subject to the Act’s prohibitions. Biotechnology companies of concern include BGI (formerly Beijing Genomics Institute), MGI, Complete Genomics, WuXi Apptec, and any subsidiary, parent, affiliate, or successor of such entities. See, e.g., 42 CFR § 430.0.

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FDA Law

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. Granted COVID has impacted regular DEA inspection schedules for most local DEA offices, but that is likely to change in the coming months.

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Management Manufacturing Specialization IT 40

FDA Law

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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Manufacturing Government Healthcare Management 72

FDA Law

OCTOBER 19, 2021

Moore & Riëtte van Laack — Last fall, when AMG Capital Management, LLC v. Supreme Court in AMG Capital Management, LLC v. By Karin F.R. forthcoming). If you haven’t heard of the Penalty Offense Authority found in Section 5 of the FTC Act, 15 U.S.C. § Chopra & Levine , supra. As we reported here , the U.S. FTC , No.

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IT Management Appointment Manufacturing 52

FDA Law

NOVEMBER 20, 2023

For example, in August, CDER and OPQ initiated the Quality Management Maturity Program (QMM) that aspires to “implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.” It is the latest item on a long list of similar initiatives that have marked 2023.

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Manufacturing Management IT Provider 59

FDA Law

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

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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Manufacturing Management Medical Provider 52

FDA Law

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.

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Manufacturing Insurance Patients IT 52

FDA Law

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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Manufacturing Engineering Clinic Provider 59

FDA Law

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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Manufacturing Provider Management IT 59

FDA Law

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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Manufacturing Asthma Diabetes Families 52

FDA Law

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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Manufacturing Supply Chain Insurance Provider 52

FDA Law

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. By Larry K.

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FDA Law

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. By Larry K.

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Management Consulting Provider Physicals 40

FDA Law

NOVEMBER 14, 2022

The facility fee applies to a single manufacturing facility. The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product.

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Manufacturing Individual Management Provider 52

GeriPal

JUNE 20, 2024

On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. Someone else suggested, “Under Pressure,” but we’ve done it already. We settled on, “Oops…I did it again,” by Britney Spears. I suggested even flow. That’s a good one.

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