FDA Law Blog

SEPTEMBER 29, 2022

As readers may recall, the current regulation provides for four options for a disclosure statement, i.e., text disclosure, symbol disclosure, electronic disclosure (QR code with a phone number for further information), and a text message disclosure. However, the Court did grant the motion on the issue of the disclosure options.

Electronics 59

Electronics Engineering Provider 59

FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents also note that FDA may request copies of the DMC meeting records when the study is completed, and access to the electronic data sets used for each set of interim analysis.

Clinic 105

Clinic Provider IT Utilities 105

Dr. Zaar

MAY 20, 2025

Today, virtual care provides quick, convenient access to expert endocrinologists. In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. If you do not have coverage, many online platforms provide inexpensive self-pay options.

Consulting 52

Consulting Insurance Appointment Telemedicine 52

FDA Law Blog

AUGUST 9, 2023

However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. at 48379 (to be codified at 21 C.F.R.

Electronics 52

Electronics Patients IT Provider 52

FDA Law Blog

OCTOBER 5, 2022

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps. add-to-files).

Electronics 45

Electronics Medical Screening IT 45

FDA Law Blog

OCTOBER 5, 2022

Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically. CDRH’s website provides a link to request access to the CCP ( here ). On October 3, 2022, CDRH announced the expansion of this program.

Electronics 59

Electronics Utilities Specialization IT 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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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.

Provider 59

Provider Electronics Manufacturing IT 59

FDA Law Blog

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). The final guidance provides additional discussion with respect to DHTs that meet the definition of a device.

Clinic 105

Clinic Manufacturing Provider Electronics 105

FDA Law Blog

JUNE 10, 2024

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. Provide both completed and planned actions and related timelines.

Provider 111

Provider Electronics Clinical Practice Management 111

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law Blog

JULY 20, 2021

FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the proposed rule. As readers of our blog know, “Product of USA” and other country of origin labeling issues on meat and poultry products have been an issue of discussion in recent years. or the Egg Products Inspection Act.

IT 76

IT Electronics Manufacturing Individual 76

FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. By Steven J. Gonzalez & Lisa M. There is no cost associated with obtaining an FEI Number.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers.

Manufacturing 74

Manufacturing Electronics Provider Clinic 74

FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

Medical 52

Medical Electronics Provider Screening 52

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law Blog

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

FDA Law Blog

JANUARY 30, 2025

But even prior to the amendments, the text of the statute, on its face, provided real time access to government records. That has been significantly undermined at FDA and other agencies by administrative backlogs, and a safety valve that Congress provided for exceptional circumstances. 552(a)(4)(B).

Government 66

Government Electronics Provider IT 66

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.

Manufacturing 59

Manufacturing Utilities Electronics IT 59

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. Providers should be aware of the other drugs prescribed to their patients. By Larry K. Complaint ¶ 62.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical 111

Medical Clinic Patients IT 111

The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. Infuse your budget, buy a new electronic, place it in cryptocurrency, whatever.

Finance 52

Finance Insurance IT Individual 52

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. electronic thermometers, single lumen needles, piston syringes).

Medical 52

Medical Electronics Complication Provider 52

PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

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.

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

FDA Law Blog

OCTOBER 18, 2023

The 510(k) Program Guidance provides several scenarios that illustrate the most common situations in which clinical data may be needed to demonstrate substantial equivalence. The Draft Guidance provides additional context and clarity to these three scenarios and adds a new scenario in which clinical data may be needed.

Clinic 64

Clinic Provider Medical Electronics 64

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

Finance 52

Finance Individual Management IT 52

FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

APRIL 19, 2023

As provided in the OMUFA Performance Goals letter , FDA issued draft guidance on the content and format of submissions. Reminders of the need to fulfill existing environmental assessment requirements and make all submissions electronically are also included. x 11-inch paper, and with hyperlinks to references and numbered pages.

Electronics 59

Electronics Provider Clinic IT 59

FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., We previously blogged on the draft guidance here.

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

SEPTEMBER 17, 2023

For example, device sponsors can request a meeting with an FDA review team by submitting a pre-submission to CDRH (see our recent blog on the minor updates to the Pre-Submission Guidance). Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law Blog

JULY 28, 2021

Registrants may also use DEA’s electronic Controlled Substance Ordering System (“CSOS”)). Allowing the purchaser to omit a supplier’s DEA registration number for the supplier to add later provides flexibility for when a supplier may have to fill an order from a different registered location than the one contemplated by a purchaser.

Electronics 52

Electronics Provider IT 52

FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. By McKenzie E. Certain types of clinical decision-support software. Medical Image Storage Device. 892.2050.

Electronics 40

Electronics Medical Management Clinic 40

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

DECEMBER 6, 2024

This summary covers everything from format and contents of INDs to their submission and use of the Electronic Submissions Gateway to cross-referencing other applications to FDAs review of the IND and the associated timelines. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

Clinic 59

Clinic Provider IT Electronics 59