The 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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post.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 note that FDA may request that the sponsor submit the DMC charter to FDA for review before the performance of any interim analyses, and ideally before the initiation of the trial.

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ISPE

SEPTEMBER 14, 2022

iSpeak Blog. introduces it thus: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action.

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Board Vitals - Pharmacist

DECEMBER 1, 2023

Patient Communication Some call it creating “happy patients,” others want to improve “patient experience,” and yet others mention “patient satisfaction.” Regardless of the term you use, communicating with patients in order to improve their care, compliance, and satisfaction is a worthy goal. It’s much easier said than done.”

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Pharmacy Is Right For Me

APRIL 4, 2023

To learn about some of the more unique career settings in the industry, check out the Novel Pharmacy Practice Settings page —where you can explore these unique career pathways such as integrated health-community paramedicine. It also improves care coordination and eliminates communication gaps.

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The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. 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.

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

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Omnicell

JANUARY 10, 2023

The Chief of Anesthesia is now aware of flaws in documentation and has an awareness of open transactions through enhanced data visibility. Team members on the diversion team regularly communicate with the pharmacy to further increase responsibility. Subscribe today.

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Omnicell

SEPTEMBER 5, 2022

In today’s complicated world, where keeping in touch with your pharmacy customers is more challenging than ever, new patient communications and engagement tools are needed. scheduling for immunizations and point-of-care testing), and improve satisfaction and retention. Visit us at enlivenhealth.co to learn more.

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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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ISPE

SEPTEMBER 28, 2023

Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.

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ISPE

MARCH 16, 2023

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. Some of these challenges include for example regulatory compliance, quality control and effective communication between the original manufacturer and the CMO.

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ISPE

JULY 24, 2023

For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.

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ISPE

MARCH 20, 2023

In context of this blog, an interface is connecting two or more systems, including transport technology and middleware where necessary. The Challenge New approaches and technical possibilities are constantly being developed to enable systems to communicate with each other and exchange data.

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ISPE

APRIL 19, 2023

An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. For example: 1.

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ISPE

FEBRUARY 14, 2023

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? After a thorough internal review, health authorities sometime release a document for public comment. Tell other interested parties about your comment.

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ISPE

SEPTEMBER 1, 2023

For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.

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The FDA Law Blog

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. CDRH As of this blog post, CDRH has not made any official announcements regarding the resumption of in-person meetings. Advisory Committee Meetings As of this blog post, all Advisory Committee Meetings that FDA has announced will be conducted via an online platform.

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Viseven

JULY 25, 2024

The truth is that MLR reviews are needed in 90% of cases, whether it is a website blog post or an important research paper. Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team.

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The FDA Law Blog

OCTOBER 31, 2022

We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. As part of the testing, FDA retrospectively reviewed applications to determine if the Excellence Appraisal could be used in lieu of certain other premarket software documents. Key Performance Indicators.

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The FDA Law Blog

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.

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ISPE

DECEMBER 6, 2022

iSpeak Blog. This blog is the second in a series of four intended to explore how we can rethink the way we support and inspire one another as we reimagine quality and validation in a digital world. Value of getting more information and context outweighs the risk of potentially having a documented path without conclusion.

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The FDA Law Blog

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

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The FDA Law Blog

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

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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. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. Disclaimer The views and opinions expressed in this blog are those of the authors. 340B providers expressed significant concern.

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The FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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ISPE

NOVEMBER 28, 2022

iSpeak Blog. The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Internal Communication.

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Roots Analysis

AUGUST 9, 2023

Integrating advance tools and technologies with manufacturing execution system (MES) ensure smooth communication within different production process, enhance decision making capability of MES and also enhance risk prediction capabilities.

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Documentation Communication 52

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. 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

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.

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The FDA Law Blog

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. cannot be altered during the transmission.

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Viseven

AUGUST 7, 2024

Medical writing refers to creating healthcare-related textual content that aims to improve doctor-patient communication and provide insights on industry topics. Medical writers must be outstanding communicators, capable of breaking down complex ideas for the public and healthcare professionals in a digestible way.

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Omnicell

SEPTEMBER 5, 2022

As a leading provider of patient engagement and communications technology solutions for retail pharmacies and health plans, EnlivenHealth® is helping pharmacies to effectively manage the COVID-19 vaccine with its recent launch of CareScheduler , a software as a service technology solution.

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

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Viseven

JULY 12, 2022

With that in mind, we highlighted the most vital channels for medical content marketers so far: Medical Websites Medical Blogs Landing Pages mHealth Apps SMS Messaging Apps Social Media Email Video. Become an Authority with an SEO-Friendly Blog. Blogging is the best way to grow a medical website organically. Be patient.

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The FDA Law Blog

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Like other guidance documents that preceded it, the draft guidance will be open to the public for comment. Once final, the guidance will be implemented and review staff will be trained.

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DiversifyRx

JULY 15, 2024

Whether it’s a new marketing technique, an efficient workflow process, or tips on managing inventory, sharing these with your peers can elevate the entire community. Encourage Open Communication: Create platforms where pharmacy owners can discuss challenges and share solutions. A great place to learn is our BLOG.

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