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?

Manufacturing 105

Manufacturing Management IT Medical 105

FDA Law Blog

JUNE 24, 2024

HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. Since its inception, the Format has been instrumental in standardizing the submission process, ensuring that critical data is presented in a clear and consistent manner.

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Manufacturing Healthcare Education Utilities 52

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. .</span></p> I only had to adjust the mesial and distal contacts using the smooth tool and the restoration was ready to manufacture.

Manufacturing 52

Manufacturing IT Patients Relationship 52

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 75

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. See 21 CFR 807.81(a)(3)

Manufacturing 98

Manufacturing Provider Medical IT 98

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> Here is how she presented:</p> <p>[image:Untitled_2_001.jpg]</p>

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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.

Manufacturing 74

Manufacturing Electronics Provider Clinic 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

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. This lawsuit was brought to the U.S. See United States ex rel. Bawduniak v. Biogen Idec, Inc. ,

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Consulting Healthcare Professional Government Specialization 105

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. See, e.g., 42 CFR § 430.0.

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Manufacturing Government Consulting IT 102

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 Congress does not, one might say, hide elephants in mouseholes.

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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 Provider Clinic IT 59

FDA Law Blog

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats. Tobolowsky — Much has changed since the long-gone days of 2017.

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IT Manufacturing Provider Clinic 64

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. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP.

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Manufacturing Electronics Provider Management 64

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 foundation of the regulatory intelligence and strategy is to remain abreast of current regulatory and legislative guidelines.

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Medical Manufacturing IT 40

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

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.

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Specialization Manufacturing Education Provider 52

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. It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code LZS.

Manufacturing 52

Manufacturing Provider Patients IT 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

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

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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

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

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

CDOCS

APRIL 14, 2021

& But, I don&rsquo;t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> & & First, you&rsquo;re getting a CEREC system for single unit posteriors.& & Yes, the Primescan is amazing.&

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IT Patients Provider Appointment 52

FDA Law Blog

JANUARY 26, 2022

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate.

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IT Education Utilities Patient-Centered 40

FDA Law Blog

OCTOBER 4, 2023

However, Judge Newman distinguished Michigan Bell from the present case because the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” See Motion at 11. Order at 22. The drug was indeed selected on August 29, 2023.

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Provider Manufacturing IT Government 59

FDA Law Blog

MARCH 30, 2025

Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. Presumably, details will follow as each action gets further underway. Specific timelines were not provided.

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Family Families Manufacturing Provider 59

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 main body of the draft guidance provides high-level recommendations, and four appendices provide detailed recommendations for test design. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

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Provider Medical Manufacturing Consulting 59

GeriPal

JUNE 20, 2024

Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. But then there is incontinence, which is the same term, same word, but actually presents as a geriatric syndrome. On our last podcast about urinary incontinence the song request was, “Let it go.” I do like that one.

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IT Patient-Centered Patients Clinic 120

FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). Supporting information is critical to illustrate the specific points of regulatory misconduct.

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Manufacturing Utilities Electronics IT 59

FDA Law Blog

MAY 23, 2023

Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

Manufacturing 45

Manufacturing IT Education 45

FDA Law Blog

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S. inventors to compete. But there’s another side to this story.

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IT Manufacturing Medical Provider 76

CDOCS

JUNE 30, 2021

Next, following manufacturer&rsquo;s instructions for use, CLEARFIL&trade; CERAMIC PRIMER PLUS (Kuraray Noritake) was applied to the intaglio of each restoration, followed by PANAVIA&trade; V5 Tooth Primer to each tooth prep, and lastly PANAVIA&trade; V5 Cement to the intaglio of each restoration prior to final seating.</span></p>

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Family Families Patients Manufacturing 40

CDOCS

MAY 4, 2021

He presented with a high smile line and desired fixed natural appearing teeth. The patient was only interested in replacing the missing lateral incisors at this time and would be satisfied with a unilateral flexi partial replacing # 2, 3 and 4. Various options were communicated for the posterior teeth which could be considered in the future.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

OCTOBER 25, 2021

Specifically, for 510(k)s, QSR inspections are prohibited unless FDA finds that “there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health.” befitted a very important pathway to market for novel medical devices. The new rule will be codified in 21 C.F.R.

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Manufacturing Government Specialization IT 52