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. Life’s experience bolsters that skepticism.This blog won’t help to heal those feelings. 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. We will discuss these actions in more detail in later blog.

Management 52

Management Manufacturing Specialization IT 52

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

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. This blog will continue to monitor how DOJ and the courts analyze the intersection between the FDCA and the FCA.

Manufacturing 72

Manufacturing Government Healthcare Management 72

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

JUNE 27, 2023

Mr. 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. This is an achievement that only around 5% of WWL-listed practitioners were accorded in 2023.

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Manufacturing Management Patients Provider 81

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

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. We will discuss these actions in more detail in later blog.

Management 40

Management Manufacturing Specialization IT 40

FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Manufacturing Electronics Provider Management 64

FDA Law

MARCH 9, 2025

FDA Law Blog is a conference media partner. John Claud will speak at a session titled Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets, where he will explore two areas of global focus for the cosmetics industry: Latin America and China.

Manufacturing 59

Manufacturing Specialization Provider Management 59

FDA Law

JUNE 6, 2021

FDA requirements applicable to sponsors of drug-led drug/device combination products, including device requirements for the quality management system and good manufacturing practices (GMPs), device content to include in a new drug application (NDA), registration and listing, and post market reporting. This webcast will cover U.S.

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Manufacturing Management 52

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

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.” We have recently blogged on this topic (“ Is my software a medical device? ”). By Philip Won & Jeffrey K.

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Specialization Provider Medical Manufacturing 105

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).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law

NOVEMBER 14, 2022

Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). 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.

Manufacturing 52

Manufacturing Individual Management Provider 52

FDA Law

OCTOBER 31, 2022

We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. 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.

Manufacturing 72

Manufacturing Specialization Management IT 72

FDA Law

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. As we have previously discussed, the Third Party 510(k) Review Program is not widely used.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

FDA Law

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. The changes made in the final rule were minimal and notably did not address two of the biggest subjects of substantive comments to the proposed rule. Further elaboration of FDAs view would be helpful.

Provider 59

Provider Healthcare Individual IT 59

FDA Law

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

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Clinic Medical Provider Patients 52

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

FDA Law

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model.

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Manufacturing Management Clinical Practice Medical 105

FDA Law

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

SEPTEMBER 8, 2022

As it stands, the rule allows insurers and pharmacy benefit managers (PBMs) to broadly use copay accumulator programs, which have long been criticized by patient advocacy groups as padding insurers’ pockets while leaving patients high and dry. These prohibitions are often referred to as copay accumulator adjustment programs.

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Insurance Patients Manufacturing Patient-Centered 83

FDA Law

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C.

Manufacturing 40

Manufacturing Patients Insurance Government 40

FDA Law

NOVEMBER 8, 2022

Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

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Medical Manufacturing Patient-Centered Provider 59