FDA Law Blog

JANUARY 18, 2022

This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”

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Medical Manufacturing Healthcare Government 98

Medical Xpress

MAY 17, 2023

A new sub-study of the STEP TEENS trial, presented at this year's European Congress on Obesity (ECO) 2023 in Dublin May 17-20, shows that adolescents using semaglutide experienced significant reductions in levels of liver enzymes that are an indicator of liver damage.

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Manufacturing IT Medical 96

Medical Xpress

FEBRUARY 16, 2023

Like any other manufactured food product, chocolate can be contaminated if key ingredients or processes break down.

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Manufacturing Clinic 98

FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Please check out FDA’s presentation on this very topic – Is My Product a Medical Device? The flowchart can be downloaded here.

Medical 23

Medical Manufacturing Electronics Provider 23

FDA Law Blog

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. This facilitated generic manufacturers access to samples of brand-name drugs not readily available through normal market channels for generic drug development.

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IT Manufacturing Provider Management 144

FDA Law Blog

JANUARY 9, 2025

A foreign food manufacturer that refuses to permit entry of [FDA inspectors} to inspect such factory, warehouse, or other establishment can be subject to an import alert under section 807(b) of the FD&C Act. FD&C Act 501(j). But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?

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Manufacturing Management IT Medical 105

FDA Law Blog

JANUARY 18, 2022

This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”

Medical 75

Medical Manufacturing Healthcare Government 75

Medical Xpress

MARCH 13, 2023

The findings also present compelling evidence that the prevalence of food additives is on the rise; manufacturers have increased the mean number of additives contained in purchased food and beverage products from 3.7 This represents a 10% increase since 2001. in 2001 to 4.5 in 2019.

Manufacturing 75

Manufacturing 75

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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Manufacturing IT Provider ER 115

CDOCS

AUGUST 11, 2021

</span></p> <p><span style="font-size:14px;">This patient presented with a chief complaint of his poorly matching crown on tooth #9. I only had to adjust the mesial and distal contacts using the smooth tool and the restoration was ready to manufacture. Today with the 5.2

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Manufacturing IT Patients Relationship 52

FDA Law Blog

JUNE 15, 2022

s Dara Katcher Levy will be presenting at the DIA 2022 Global Annual Meeting being held this June 19-23 in Chicago, IL. Hyman, Phelps & McNamara, P.C.’s

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Healthcare Manufacturing Medical 40

FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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Manufacturing Provider Medical IT 98

FDA Law Blog

AUGUST 8, 2023

All of these deviations discussed in FDA inspectional observations and Warning Letters have caused serious issues for manufacturers of APIs or finished drug products. Perhaps most importantly, the guidance concludes with examples of how manufacturers would apply this framework to Nitroso compounds.

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Manufacturing Electronics Clinic Provider 74

FDA Law Blog

JANUARY 29, 2023

Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.

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Manufacturing Consulting Government IT 59

CDOCS

MAY 11, 2019

& Patient presents as an 80 year old woman who was wearing an ill fitting partial for awhile and was losing weight because eating was very difficult. & Here is how she presented:</p> <p>[image:Untitled_2_001.jpg]</p> jpg][image:Untitled_2_006.jpg][image:Untitled_2_007.jpg][image:Untitled_2_008.jpg]</p>

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Manufacturing IT Patients Illness 52

FDA Law Blog

DECEMBER 11, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (See our post on this rule here.)

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Manufacturing Management Provider Government 59

FDA Law Blog

DECEMBER 9, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (See our post on this rule here.)

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Manufacturing Management Provider Government 59

FDA Law Blog

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.

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Manufacturing Management Government 59

FDA Law Blog

MARCH 3, 2024

The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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Manufacturing Government Consulting IT 102

FDA Law Blog

DECEMBER 21, 2021

This session will highlight current guidance documents that are of key importance to device and diagnostic manufacturers and regulatory intelligence executives. The magnitude of guidance documents affecting a product throughout its lifecycle makes this a continual challenge for regulatory teams.

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Medical Manufacturing IT 40

FDA Law Blog

APRIL 2, 2025

FDA and the court agreed that the law does not require manufacturers to get preapproval before using a substance the manufacturer believes to be GRAS. The Government argues that the FDCA is silent on whether the manufacturer must notify FDA of GRAS conclusions. [A]s

Manufacturing 59

Manufacturing Government IT 59

FDA Law Blog

NOVEMBER 1, 2022

Some key points the Agency shared included the following: Your product is only as good as the process-demonstrate your manufacturing process consistently produces drug product as per your critical process parameters (CPPs). Agency often sees issues when the drug product is put on an expedited manufacturing or an expedited clinical program.

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Manufacturing Clinic Provider IT 59

FDA Law Blog

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

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Hospital Manufacturing Specialization Medical 52

FDA Law Blog

OCTOBER 3, 2022

For example, the government closely scrutinizes speaker programs or trainings that involve lavish venues or meals and free alcohol, invite attendees with no legitimate business reason to attend, and present little substantive information to them. Today, these two documents are key in navigating speaker programs in the industry.

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Consulting Healthcare Professional Specialization Government 105

FDA Law Blog

AUGUST 13, 2023

The information is presented in a Q&A format. Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In addition to the mandatory information to be submitted (i.e.,

Manufacturing 52

Manufacturing Electronics IT 52

FDA Law Blog

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. By McKenzie E. Cato & Alan M. not friends, significant others, or family members of a speaker or invitee).

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Specialization Manufacturing Education Provider 52

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).

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Manufacturing Electronics Provider Management 64

FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. The approved devices already have patient‑directed labeling that FDA has approved. What is going on here?

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Manufacturing Provider Patients Medical 52

FDA Law Blog

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 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. Nevertheless, the Agency believes this bifurcated system presents public health risks, and needs to be corrected by bringing LDTs under the FDA’s general IVD regulatory framework.

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Manufacturing Clinic Screening Healthcare 59

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).

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Featuring speakers from the USPTO, FTC, FDA, distinguished members of the Judiciary, and in-house and outside counsel, HP&M Director Kurt Karst will be a presenter at the 20th Annual Paragraph IV Disputes Conference , April 25 – 26 in New York, NY.

Management 59

Management Manufacturing Specialization Government 59

FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Provider Electronics Manufacturing IT 59

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. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

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Manufacturing Engineering Medical IT 64

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. The basis of this conclusion relates to the large range of device indications and technology and nuances of testing to support them.

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Manufacturing Specialization Management IT 72

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

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Provider Medical Manufacturing Consulting 59

CDOCS

MAY 4, 2021

He presented with a high smile line and desired fixed natural appearing teeth. The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings. Various options were communicated for the posterior teeth which could be considered in the future.

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Patient-Centered Patients Manufacturing Clinic 52