The FDA Law Blog

FEBRUARY 2, 2025

Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate. By Sophia R. Gaulkin — Last week, the U.S.

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Omnicell

JANUARY 10, 2023

Interoperability shifts these behaviors, allowing nurses to: Locate alternative medication storage areas Remotely document waste Remotely queue medications for multiple patients so one can focus on other tasks After nurses review the MAR for available medications, they can communicate with the pharmacy through PowerChart. Subscribe today.

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ISPE

MAY 1, 2023

It often took me multiple weeks of Computer Based Training (CBT) and reading documents. I created the templates in my own time and first only used them for my own information, as a reference book, instead of using the regulations to review compliance of CSV documents and controls. Several times I even didn’t pass the exams.

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The FDA Law Blog

APRIL 14, 2025

As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards. When using ASCA, Summary Test Reports are included in a premarket submission using the format provided in the ASCA standards-specific guidance documents.

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The FDA Law Blog

DECEMBER 12, 2022

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations. It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop.

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IDStewardship

MARCH 12, 2023

Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant. This blog post I did may also be of interest, on the topic. Daptomycin: from the mountain to the clinic, with essential help from Francis Tally, MD Find it here.

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ISPE

APRIL 12, 2023

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases.

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The FDA Law Blog

AUGUST 16, 2023

Document dumps,” he said, are not helpful without the assistance of a narrative placing the documents in context.

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ISPE

SEPTEMBER 14, 2023

ISPE GAMP SIG MES Planning to Move the Industry Forward Trudy Patterson Thu, 09/14/2023 - 11:49 iSpeak Blog iSpeak ISPE GAMP SIG MES Planning to Move the Industry Forward Christian Woelbeling Dirk Sweigart, BSME, BSCS, MBA Mark J. Watch the ISPE iSpeak Blog page for future updates.

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ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. However, for higher risk data (i.e., This would satisfy the requirement under PICS section 8.11

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The FDA Law Blog

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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ISPE

SEPTEMBER 14, 2022

iSpeak Blog. It’s focusing on what matters, which has to be quality instead of compliance and documentation. What about capturing the requirements into a word document versus using a requirements management tool? Documentation alone is no defence against defects. Why We All Need Critical Thinking. Trudy Patterson.

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The FDA Law Blog

JANUARY 10, 2023

An accompanying blog post touts the new Guidance as potentially “one of the most important documents you’ll read in 2022.” Rather, it is “intended to help advertisers comply with the basic tenets of FTC law,” and as stated in FTC’s blog post, “it offers practical perspectives from FTC staff.”

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The FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). Details of the PCCP will be publicly available (i.e.,

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pharmaphorum

JANUARY 13, 2021

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

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The FDA Law Blog

APRIL 10, 2025

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.

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The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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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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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. . However, typing hashtags manually or copying and pasting them from another document takes time to add them to your posts. Scheduling allows you to plan your social media content. Hashtag groups.

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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. . However, typing hashtags manually or copying and pasting them from another document takes time to add them to your posts. Scheduling allows you to plan your social media content. Hashtag groups.

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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. . However, typing hashtags manually or copying and pasting them from another document takes time to add them to your posts. Scheduling allows you to plan your social media content. Hashtag groups.

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Labelling Customer Service Documentation 52

PharmD Live

JUNE 2, 2025

Proven Track Record: Documented success, strong references, and positive client outcomes. Action Steps: Protecting Your Practice in 2025 Vet RPM Vendors Rigorously: Demand transparency, compliance documentation, and references. Full-Service Delivery: Education, device supply, and treatment management for every patient. link] AASM.

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Blog: Ask a Student Pharmacist

DECEMBER 31, 2024

Frances Abanonu Abanonu started a blog to document her experiences as a mom attending school, to both encourage herself and other mothers. After I had my kids, I told my husband I want to go to pharmacy school this is what I've always wanted to do I'm still thankful for the routes that I took because every experience is valuable.

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DiversifyRx

MARCH 27, 2025

In this blog, Im going to break down the two biggest red flags you need to watch for so you can avoid costly mistakes and keep your pharmacy protected. Ask for EIN, 501(c)(3) documentation, and referencesbut know that these can even be faked. Vague mission or unverifiable charity status. Pressure to ship immediately.

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PharmD Live

JUNE 23, 2025

PharmD Live’s board-certified clinical pharmacists manage and monitor the RPM service, record and document patient health metrics, and provide monthly billing reports, reducing provider workload without sacrificing care. PharmD Live blog. AMBCI Medical Billing & Coding Certification Blog. Published June 4, 2025. PharmD Live.

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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.

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ISPE

AUGUST 17, 2023

The digitization of paper forms and documents has been a crucial first step in this process, but now we are seeing a shift towards the electronic generation and management of data. For one, electronic data can be stored and accessed more easily than physical documents.

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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. 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. We look forward to it.

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The FDA Law Blog

DECEMBER 15, 2024

In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. In fact, nearly all of the CMC comments are directing us to existing guidance documents. The guidance documents that CBER has issued in recent years in the CGT space have been important steps forward.

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The FDA Law Blog

DECEMBER 4, 2023

Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution. The order also enjoins the pharmacist-owner from serving as a PIC at any other pharmacy for seven years. Consent Agreement and Final Judgment ¶ 17.

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The FDA Law Blog

FEBRUARY 7, 2023

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.

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The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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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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The FDA Law Blog

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time.

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ISPE

NOVEMBER 23, 2022

iSpeak Blog. He said that PIC/S had identified the need for GMP inspectors to be provided with training and guidance documents on how to evaluate Pharmaceutical Quality Systems, with training material currently being developed. ISPE Represented at PIC/S 50th Anniversary Event. Trudy Patterson. Wed, 11/23/2022 - 06:50. 23 November 2022.

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The FDA Law Blog

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject.

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