The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

Labelling 52

Labelling FDA Documentation 52

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. We have recently blogged on this topic (“ Is my software a medical device? ”). Per section 3305(e) of the Omnibus, FDA must provide an updated guidance document by December 2024. Loose Ends IDEs.

FDA 105

FDA Documentation Labelling Communication 105

The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . Labeling systems. If your company’s content calendar has a rainbow of colorful labels, translate your organizational system to your scheduling tool. Hashtag groups. Key Features.

Labelling 52

Labelling Customer Service Community Pharmacies Documentation 52

The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . Labeling systems. If your company’s content calendar has a rainbow of colorful labels, translate your organizational system to your scheduling tool. Hashtag groups. Key Features.

Labelling 52

Labelling Customer Service Documentation 52

The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . Labeling systems. If your company’s content calendar has a rainbow of colorful labels, translate your organizational system to your scheduling tool. Hashtag groups. Key Features.

Labelling 52

Labelling Customer Service Documentation 52

The FDA Law Blog

FEBRUARY 7, 2023

Part 820), labeling (21 C.F.R. In practice, a standard operating procedure for design controls is developed to describe how medical device design will be performed and documented. First, a design history file includes many documents that must be submitted as part of a 510(k), De Novo, or premarket approval (PMA) application.

Documentation 98

Documentation FDA Labelling 98

The FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023.

Documentation 52

Documentation FDA Labelling 52

The 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 ). FDA also requests a “detailed description of the allegation with any available supporting documentation.”

FDA 59

FDA Documentation Labelling Communication 59

The FDA Law Blog

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different. The new § 820.10

FDA 59

FDA Labelling Packaging Documentation 59

pharmaphorum

OCTOBER 27, 2022

Blogs – A company is free to own a blog or engage a blog writer by way of sponsorship or consultancy fees. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

Documentation 52

Documentation Labelling Communication FDA 52

The FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

FDA 76

FDA Documentation Packaging Communication 76

The FDA Law Blog

OCTOBER 26, 2022

Examples of where we would generally consider preventing the FDA investigator from fully conducting an inspection include… [t]he owner, operator, or agent in charge refuses to allow the FDA investigator to collect evidence to document potential violations (e.g., That’s a long time to potentially lose access to the U.S. See here and here.

FDA 59

FDA Labelling Documentation 59

The FDA Law Blog

MAY 8, 2023

a) , and related guidance documents (e.g., 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) a)(3) and 21 CFR 814.39(a)

FDA 98

FDA Documentation Labelling 98

The FDA Law Blog

JULY 24, 2025

FDA notes that the sale or transfer of a 510(k) may involve changes to labeling, such as the name of the place of business and/or the device brand and model name, which likely requires a new unique device identifier (UDI) and as such will also require an update submission to FDA’s Global Unique Device Identification Database (GUDID).

Documentation 52

Documentation FDA Labelling 52

The FDA Law Blog

APRIL 19, 2023

The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD). x 11-inch paper, and with hyperlinks to references and numbered pages.

Documentation 59

Documentation FDA Labelling 59

The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. 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.

FDA 52

FDA Labelling Documentation Communication 52

The FDA Law Blog

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. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Documentation 45

Documentation FDA Labelling Communication 45

The FDA Law Blog

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. To learn more about our experience with the eSTAR for 510(k)s, check out our previous blogs ( here , here ).

FDA 52

FDA Documentation Labelling 52

The FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Labelling 45

Labelling Packaging FDA Documentation 45

Omnicell

JANUARY 10, 2023

For one thing, anesthesia workstations include safety features, such as the ability to print out color-coded labels for syringes, which can help prevent harmful medication errors. We’ve developed closed-loop functionality that makes it easier for providers to document waste, improving the likelihood of compliance.

Controlled Substances 52

Controlled Substances Omnicell Medication Dispensing Documentation 52

Viseven

JULY 25, 2024

billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry. The truth is that MLR reviews are needed in 90% of cases, whether it is a website blog post or an important research paper. For example, Pfizer was fined $2.3

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

MAY 15, 2023

States frequently review labels (and labeling) for animal food products. The CFI includes a list of common foods that “may be appropriate for use in animal food and serve as a tool for use during review of ingredients on an animal food label.” This document also describes an appeal procedure.

Labelling 45

Labelling Documentation FDA 45

Omnicell

JANUARY 10, 2023

Omnicell continues to collaborate with ISMP to improve pharmacy-nursing efficiency, reduce medication errors during dispensing, and support accurate medication tracking and documentation of inventory and deter drug diversion. Watch this webinar to learn more about how automated dispensing systems support ISMP guidelines for medication safety.

Omnicell 52

Omnicell Documentation Labelling Patient Care 52

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

FDA 52

FDA Labelling Packaging Documentation 52

The FDA Law Blog

AUGUST 10, 2022

Nor does FDA have the authority to look beyond the Lumryz labeling to its REMS document for a use that overlaps with the listed use code, Avadel argues. Another interesting question this suit raises is whether FDA can look beyond the labeling to determine whether a section viii carve-out is acceptable.

FDA 52

FDA Labelling Documentation 52

The FDA Law Blog

OCTOBER 11, 2022

Even in the absence of a guidance document dedicated to explaining FDA’s views on interpreting the statutory construct of “confirmatory evidence,” a number of drug approvals over the past few years give us a great deal of insight into FDA’s current thinking and how FDA is applying this standard.

FDA 61

FDA Documentation Labelling 61

The FDA Law Blog

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R. Dr. Shuren further elaborated that he hopes the final rule will be “out by the end of this year.”

Documentation 52

Documentation FDA Labelling 52

The FDA Law Blog

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. The monitoring protocol also needs to include plans to update labeling with the additional performance data. Customer Support Help line).

Labelling 40

Labelling FDA Documentation 40

The FDA Law Blog

FEBRUARY 28, 2024

On July 7, 2023, armed with these new procedures, CDER notified Oncopeptides that it proposed expedited withdrawal of Pepaxto because the postapproval study failed to verify clinical benefit and because Pepaxto was not shown to be safe or effective under its conditions of use (the documents discussed herein are published in the docket here ).

FDA 59

FDA Documentation Labelling 59

The FDA Law Blog

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

FDA 64

FDA Documentation Labelling Medical Records 64

The FDA Law Blog

FEBRUARY 22, 2023

The only exception for a modified device is when there were no changes to: the user interface; intended device users; intended device uses; intended use environment(s); training or labeling. as a de novo special control or in a guidance document for a specific device type).

FDA 64

FDA Documentation Labelling Hospitals 64

The FDA Law Blog

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. By Douglas B. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

FDA 45

FDA Packaging Documentation Labelling 45

The FDA Law Blog

SEPTEMBER 6, 2022

The Draft Guidance continues to list the regulatory requirements to obtain authorization for charging in a clinical trial setting: (1) evidence that the drug has a potential clinical benefit that would provide a significant advantage over available products; (2) the data to be obtained from the trial would be essential to establishing that the drug (..)

FDA 52

FDA Documentation Labelling 52

The FDA Law Blog

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

FDA 59

FDA Packaging Documentation Labelling 59

The FDA Law Blog

FEBRUARY 27, 2023

Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. Helpful practitioner prescribing guidance is set forth in a simplified document here. Stay tuned.

Controlled Substances 59

Controlled Substances FDA Documentation Labelling 59

The FDA Law Blog

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

Documentation 45

Documentation Dosage Labelling 45