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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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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Documentation FDA 97

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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Documentation FDA 98

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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Documentation 98

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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Documentation FDA 98

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In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to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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Documentation FDA 119

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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Medication Guidelines Documentation Labelling Hospitals 299

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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Documentation Communication 97

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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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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Vaccines Documentation 82

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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Inventory Audits Insurance Documentation 52

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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Documentation FDA 64

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 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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Documentation FDA Labelling 52

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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Documentation Hospitals 52

pharmaphorum

DECEMBER 7, 2022

Reuters said it has interviewed 20 current and former Neuralink employees in its investigation, as well as reviewing internal company documents. In one incident, it alleges, 25 of a cohort of 60 pigs were implanted with devices that were the wrong size, while others include rushed surgeries that have caused needless pain to animals.

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Medical Records Documentation 122

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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Documentation 98

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 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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Controlled Substances Documentation Dosage Prescription Filling 139

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

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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FDA Documentation Labelling Communication 59

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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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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Documentation FDA Communication 98

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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Documentation FDA Packaging 59

Fossil Remedies

APRIL 26, 2022

If yes, then there are some tips in this blog. Gather all documents. Documentation is an important, essential, and unavoidable step. When a PCD pharma business is launched, you need some documents mandatorily. The Drug License Number and GST Number are these two documents. The first thing is a market research.

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Documentation 59

ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

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Documentation FDA 98

ISPE

SEPTEMBER 15, 2022

iSpeak Blog. On 24 August 2022, Annex 1 was published by the European Commission after consultations with WHO, PIC/S and FDA Implementation time for this document has been extended to one year for the global document, the clause 8.123 for loading and unloading lyophilizers has a two-year period of implementation.

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Documentation FDA 97

The FDA Law Blog

NOVEMBER 6, 2023

Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different. RIEs will require the facility to accommodate the “use of teleconference, livestream video, and screen sharing of data and documents.” We should explain what RIEs are.

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FDA Documentation Medical Records 105

pharmaphorum

APRIL 6, 2021

The blog, which covers lifestyle topics and reviews events and products, was even nominated for a National Diversity Award last year. “It It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says.

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Documentation 132

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. The Omnicell Blog is the leading source for pharmacy care, exploring emerging trends, successful best practices, and ideas and insights focused on the digital transformation of pharmacy.

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Omnicell Medication Dispensing CPhT Documentation 52

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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Documentation Communication 52

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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Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

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.

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Communication Packaging Documentation Pharmaceutical Companies 98

The Pharmacist Blog

MARCH 21, 2015

It can significantly affect how much work I can crank out (Example: only 2 blog posts were made for February and March is not looking so good either). Even in this blog I document my goals and publicize them to hold myself accountable. The post How to Stay Motivated appeared first on The Pharmacist Blog.

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Documentation 52

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. We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Compounding 98

IDStewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Wishing the best to the new residents and I hope this blog post helps to stimulate some young minds! The jump from PGY2 to clinician is significant.

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Communication Documentation Vaccines 130

Board Vitals - Pharmacist

DECEMBER 1, 2023

To simplify our EHR and make documentation easier and quicker. I hope to work with different EHRs to find one where surgeons can put the focus back on the patient and allow the surgeon to quickly and completely document the encounter. It’s much easier said than done.”

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Communication Patient Care Documentation Insurance 98