FDA Law Blog: Biosimilars

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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Putting Patients First Blog

JANUARY 11, 2024

The PEMT was created to better capture patient experience data more holistically, helping researchers engage and document patients’ experiences before a diagnosis, post diagnosis, while living with and during treatment of a chronic disease. In the U.S., it is estimated that about 37 million adults live with chronic kidney disease (CKD).

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Mayo Clinic Documentation 111

FDA Law Blog: Biosimilars

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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Documentation Labelling Communication 57

FDA Law Blog: Biosimilars

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 97

Putting Patients First Blog

AUGUST 15, 2024

hosted a series of workshops with patients, patient organizations, industry, and other stakeholders to develop a document known as the ‘Patient Experience Dossier’ (PED). In 2022 and 2023, the National Health Council, in partnership with Applied Patient Experience, LLC.,

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Documentation Drug Development 52

Putting Patients First Blog

SEPTEMBER 13, 2024

In 2016, the National Health Council (NHC) launched its Value Classroom , which consists of eight documents, glossaries, and infographics intended to educate patient organizations about important topics in patient-centered value assessment. Patient voices and perspectives should be centered in the development of value models.

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Documentation 52

FDA Law Blog: Biosimilars

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.

Documentation 117

Documentation 117

epicur

NOVEMBER 10, 2022

The following blog is written by Epicur Pharma’s Advisory Council member Jan Woods, a veterinary hospital consultant, and national speaker with expertise in DEA compliance, state and federal regulations, and clinic and hospital practice management. If so, did you document it? Mistakes happen – bottles spill or break.

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FDA Law Blog: Biosimilars

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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Documentation Adverse Reactions Communication Drug Development 104

Express Pharma

NOVEMBER 30, 2024

While tools such as spreadsheets, PDFs, and text documents have helped companies transition from paper notebooks, new integrated solutions offer the opportunity to revolutionise productivity and the user experience.

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Documentation Communication 78

RX Note

MAY 21, 2023

NOTE: Every HTML document starts with a document type declaration: This declaration sets the document type and ensures proper rendering of the page. Introduction HTML, or HyperText Markup Language, is the fundamental language used to create web pages. HTML Elements HTML elements are the building blocks of web pages.

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FDA Law Blog: Biosimilars

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.”

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Documentation Labelling 67

Putting Patients First Blog

NOVEMBER 16, 2023

The dossier model and disease-specific dossiers would be living documents updated over time, with patient organizations being the lead owners of these data. A PED dossier template would describe a consistent format (e.g., expected headers and content). representativeness of research to date, known unknowns).

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Documentation 52

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

Putting Patients First Blog

JANUARY 22, 2024

There are customizable health literacy checks content developers can include when reviewing their documents. Users simply upload their document directly into the Clear-AI digital platform and receive suggested feedback and readability scores on their respective content. Other Blogs: What is Health Literacy and Why is it Important?

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Documentation Communication Hospitals 40

FDA Law Blog: Biosimilars

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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Documentation 104

RX Note

APRIL 21, 2023

Introduction Occasionally, I consider compiling all the blog posts here into an offline eBook, so that learning can be done offline. Insert Page Number To start inserting page number, you can either double click header or footer section of the document, a new tab of "Header & Footer".

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Documentation 52

Putting Patients First Blog

FEBRUARY 5, 2024

Membership in the NHC allows organizations to enhance their public profile and outreach by: Submitting content for the NHC’s weekly member newsletter, NHC Insider ; Highlighting your organization and activities via a guest post on the NHC Putting Patient First blog ; and Promoting job openings in your organization on the NHC Job Bank.

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Documentation Communication 59

Syner-G

OCTOBER 27, 2023

Poor documentation. Accurate and complete regulatory documentation is vital to IND application success. The only way to avoid this roadblock is by taking the time necessary to prepare complete, comprehensive, and accurate documentation that follows all existing guidelines for each submission component.

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Documentation Drug Development 52

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. By Larry K. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

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Controlled Substances Dosage Documentation 52

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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Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

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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Documentation Labelling Communication 104

FDA Law Blog: Biosimilars

OCTOBER 26, 2023

Walsh — In our June blog post , we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. name and model of medical device and detailed description of the allegation with any supporting documentation) versus non-required.

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Documentation 52

National Association of Boards of Pharmacy

OCTOBER 23, 2024

The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” FDA took the right approach balancing the advancement of DSCSA implementation with risk of potential impacts to the flow of medicine.

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Packaging Documentation Pharmacy Technician 49

FDA Law Blog: Biosimilars

MARCH 7, 2023

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. This may result in the need to create additional documents that you may not necessarily need under the quality system.

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Documentation Communication 57

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

FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Drug Development Documentation 52

FDA Law Blog: Biosimilars

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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Documentation Labelling Communication 44

Putting Patients First Blog

SEPTEMBER 27, 2023

Among many other things, CHWs have been instrumental in mitigating the health disparities documented in the Hispanic/Latino/a/x community. Hispanics/Latinos/as/x are the fastest growing historically underrepresented racial ethnic groups and experience some of the highest mortality rates of certain chronic diseases.

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Documentation 59

FDA Law Blog: Biosimilars

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

Fuld & Company Blog

MARCH 28, 2024

” We went through a massive pile of over 5,000 documents, including scientific studies, patents, blog posts, news articles, and information from company websites, to come up with solid advice for our client.

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Documentation 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. To learn more about our experience with the eSTAR for 510(k)s, check out our previous blogs ( here , here ).

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. The new § 820.10

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Labelling Packaging Documentation 57

FDA Law Blog: Biosimilars

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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Documentation Medical Records 103

FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. PM Counsel John Claud to testify yesterday about FDA’s foreign inspection program. Mr. Claud frequently counsels foreign and domestic clients on issues relating to inspections and cGMP remediations.

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Documentation 52

FDA Law Blog: Biosimilars

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. Attachment number) and document name or description as appropriate.

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Documentation Packaging Communication Labelling 75

Syner-G

AUGUST 17, 2023

The process control strategy doesn’t remain confined to mere documentation, it reaches regulatory recognition. Having a well-developed and well-documented process control strategy provides a comprehensive summary of process understanding. This validation process ensures alignment with the intended performance objectives.

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Documentation 52