The FDA Law Blog

NOVEMBER 29, 2023

See our prior blog post on the topic here. Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions.

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The FDA Law Blog

JUNE 18, 2025

If a company receives a voucher, it must meet certain requirements to qualify for expedited review: an applicant must submit the CMC portion of its application and draft labeling at least 60 days prior to the final application submission and be available for “ongoing communication with prompt responses to FDA inquiries.”

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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The FDA Law Blog

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. We have recently blogged on this topic (“ Is my software a medical device? ”). It applies whether the software is the entire device (i.e.,

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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 ). As we discussed in our prior blog post, there needs to be a better way to understand the outcome of FDA’s review.

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The FDA Law Blog

AUGUST 11, 2024

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The Mirati letter deals with much more nuanced issues than the letter to kaleo.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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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.

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The FDA Law Blog

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. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling. Other medical information.

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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. New Labeling Requirements. Option to Automate the 510(k) Summary.

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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

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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. separate patient labeling).

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ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. By Li Jie of ClinsChain

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ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit. By Li Jie of ClinsChain

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The FDA Law Blog

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. Corrections and Removals Under 21 CFR Part 806, manufacturers generally need to communicate corrections and removals (i.e., It should be noted that 21 CFR 803.18(b)(1)(ii)

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The FDA Law Blog

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling.

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Roots Analysis

DECEMBER 10, 2023

Philips responded by updating instructions and labeling for all affected CPAP and BiPAP machine masks, explicitly warning about possible magnetic interference and listing metallic implants as contraindications. Source 1: [link] Source 2: [link] The post Magnetic CPAP Masks: A Growing Concern for Patient Safety appeared first on Blog.

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Viseven

APRIL 11, 2023

This may include blog posts, whitepapers, videos, podcasts, or infographics. The most suitable formats for pharma are eDetailers, infographics, case studies , blog posts, articles, and so on. For example, blog articles and social media posts may be most effective during awareness.

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The FDA Law Blog

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

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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. Proposed practitioner recordkeeping obligations.

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Pharma Marketing Network

JUNE 11, 2020

We may do some things like you were talking about where we have advertorials, and it’s clearly labeled as an advertorial. RJ Lewis (EHS): So today everybody’s a publisher, part of the beauty of the web and even if you don’t have the technical skills for firing up a website or a blog, which is pretty easy.

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The FDA Law Blog

MAY 11, 2023

Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. GSK skinny label case , the U.S. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of the U.S.

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The FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] report certain device malfunctions, and.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

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Digital Pharmacist

MAY 25, 2023

In this blog post, we will explore the common causes of medication errors and share seven effective strategies to enhance medication safety and best practices for reducing medication errors in the pharmacy. Properly organizing medication bottles in a systematic manner where the label is visible may be a good idea.

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Colors Make me Happy

APRIL 12, 2021

By healthy modeling, a child learns how to show anger appropriately, how to maintain healthy boundaries, how to recover from mistakes, how to communicate, how to be a being, how to cope with stress, and how to self-love. Drop the labels: You are more than a stereotype. We live in a society that has reduced us to labels.

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The FDA Law Blog

NOVEMBER 29, 2022

We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). Clinicians should review FDA-approved labeling and weigh benefits and risks before beginning pharmacologic therapy. 2022 Guideline at 15. (We 2022 Guideline at 3.

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The FDA Law Blog

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Would any such failure to meet DAP goals be reflected in labeling?

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The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression.

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Oswald's

APRIL 8, 2025

We Dont Just Slap a Label On It When it comes to your health, every detail matters. Its one of many ways were putting our patients and our community first. What Actually Happens When You Fill a Prescription Weve heard a few folks say things like its just slapping a label on a bottle, right? Every single time. We Make It Easy.

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The 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.

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The FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. in Duchenne Muscular Dystrophy). The discussion provides a wide-ranging and much needed update on FDA policies and interpretation of its accelerated approval authorities.

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The FDA Law Blog

JANUARY 22, 2025

Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not automatically think of Phil Collins classic song Sussudio ? By Jeffrey N. Other than anyone under 50, that is.

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The FDA Law Blog

FEBRUARY 5, 2025

Labeling Labeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A

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The FDA Law Blog

FEBRUARY 20, 2025

In fact, FDA has three guidances on its A list planned for this fiscal year that are specifically related to the LDT Rule or IVD (which FDA says includes LDTs) labeling (see here ). This inability to consult external experts could make communicating with FDA on important topics of safety and effectiveness even more challenging.

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The FDA Law Blog

MAY 13, 2025

Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have. Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations.

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