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.)

Medical 105

Medical Manufacturing Provider Management 105

Medical Xpress

JANUARY 4, 2023

New research in the INFORMS journal Manufacturing & Service Operations Management finds that Medicare Advantage (MA), the largest healthcare capitation program in the U.S., unintentionally incentivizes health plans to cherry-pick profitable patients from traditional Medicare (TM).

Patients 92

Patients Manufacturing Healthcare Management 92

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.

Manufacturing 105

Manufacturing Provider Management IT 105

FDA Law

MAY 29, 2025

As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. 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

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act.

IT 144

IT Manufacturing Provider Management 144

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.

Manufacturing 45

Manufacturing Provider IT Management 45

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.

Management 52

Management Manufacturing Specialization IT 52

Medical Xpress

FEBRUARY 9, 2023

New research in the journal Manufacturing & Service Operations Management finds that pooling resources to have cross-trained fire-medics respond to both emergency medical calls and fire incidents, rather than having firefighters respond to fires and emergency medical personnel respond to medical incidents, can save more than $3 million a year.

Manufacturing 80

Manufacturing Management Medical 80

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.

Management 45

Management Manufacturing Supply Chain Provider 45

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.

Manufacturing 105

Manufacturing Management Medical Provider 105

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.

Manufacturing 71

Manufacturing Management Specialization Provider 71

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.

Manufacturing 98

Manufacturing Provider Medical IT 98

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.

Medical 52

Medical Supply Chain Hospital Healthcare 52

CDOCS

FEBRUARY 14, 2025

png]</p> <h3><span style="font-size:14px"><strong>Bulk Download of Patient Files</strong></span></h3> <p><span style="font-size:12px">Managing& patient data is now easier with bulk download functionality.

Management 52

Management Manufacturing Patients Specialization 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.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law

DECEMBER 11, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. Once you register, youll receive instructions by email on how to access the webinar.

Manufacturing 59

Manufacturing Management Provider Government 59

FDA Law

DECEMBER 9, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. Once you register, youll receive instructions by email on how to access the webinar.

Manufacturing 59

Manufacturing Management Provider Government 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.

Family Physician 52

Family Physician Insurance Finance Individual 52

FDA Law

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

Manufacturing 59

Manufacturing Management Government 59

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

Manufacturing 40

Manufacturing Healthcare Management IT 40

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.

Management 40

Management Manufacturing Specialization IT 40

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.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

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.

Manufacturing 98

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.

Family Medicine 52

Family Medicine DO Screening Specialization 52

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.,

Manufacturing 72

Manufacturing Government Healthcare Management 72

FDA Law

MARCH 30, 2023

DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical requirements in Houston on May 2-4, 2023. DEA will offer virtual accessibility to those who cannot attend in person.

Supply Chain 59

Supply Chain Manufacturing Management 59

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.”

Management 113

Management IT Manufacturing Provider 113

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. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

Manufacturing 64

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.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law

JUNE 27, 2023

Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. In addition to Mr.

Management 81

Management Manufacturing Patients Provider 81

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.” The changes at OPQ are the latest in FDA’s expanded 2023 quality efforts.

Manufacturing 59

Manufacturing Management IT Provider 59

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. An average doctor will then be able to easily work with the radiological AI software, the AI software managing the EMRs, and the fourth, and eighth (etc. ) AI used in the hospital.

Healthcare 53

Healthcare Healthcare Professional Electronics Medical 53

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.

Manufacturing 59

Manufacturing Provider Management IT 59

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

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

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.

Manufacturing 52

Manufacturing Management Medical Provider 52

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.

Specialization 105

Specialization Provider Medical Manufacturing 105

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.

Manufacturing 52

Manufacturing Insurance Patients IT 52