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.

Documentation 97

Documentation 97

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).

Mayo Clinic 111

Mayo Clinic Documentation 111

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In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to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

Documentation 119

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.

Vaccines 82

Vaccines Documentation 82

FDA Law Blog: Biosimilars

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Documentation 64

Documentation 64

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post.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.

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

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.

Medical Records 122

Medical Records Documentation 122

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.

Documentation 105

Documentation Labelling Communication 105

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.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

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.”

Documentation 59

Documentation Labelling Communication 59

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.

Documentation 105

Documentation 105

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.

Documentation 59

Documentation Packaging 59

National Association of Boards of Pharmacy

DECEMBER 4, 2024

These voluntary standards provide clear guidelines on personnel, equipment, training, and documentation, ensuring that patients receive medications that are safe and free from contaminants. Proper training covers compounding techniques, safety protocols, and documentation, reducing the risk of errors that could impact patient safety.

Compounding Pharmacies 49

Compounding Pharmacies Compounding Documentation Sterile Compounds 49

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.

Controlled Substances 52

Controlled Substances Documentation Compounding Pharmacies Compounding 52

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.

Documentation 105

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.

Documentation 132

Documentation 132

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.

Communication 98

Communication Pharmaceutical Manufacturing Packaging Documentation 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.

Documentation 52

Documentation 52

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.,

Documentation 52

Documentation Drug Development 52

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.”

Communication 98

Communication Documentation Diabetes 98

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.

Documentation 52

Documentation 52

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.

Documentation 52

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.

Documentation 75

Documentation Packaging Communication Labelling 75

FDA Law Blog: Biosimilars

JUNE 10, 2024

Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. Provide a method of verifying or monitoring the effectiveness of the actions. training, standard operating procedure (SOPs), corrective action plans, records, etc.).

Communication 111

Communication Documentation 111

FDA Law Blog: Biosimilars

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

Documentation 105

Documentation 105

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.

Documentation 59

Documentation Communication 59

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).

Documentation 52

Documentation 52

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".

Documentation 52

Documentation 52

Pharmacy Joe

MAY 1, 2024

A total of 184 patients met the criteria of presenting to the ED and being admitted for bacterial infection, having a reported beta-lactam allergy history that was moderate, severe, or unknown in nature, and who did not have a documented history of beta-lactam tolerance.

Inpatient 98

Inpatient Medical Records Documentation Labelling 98

Express Pharma

JUNE 2, 2023

By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation. Quality control and regulatory compliance: Traceability is crucial for maintaining quality control and ensuring compliance with stringent regulations in the medicine space.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

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.

Documentation 59

Documentation Communication 59

PharmD Live

JANUARY 22, 2025

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. To stay viable, physicians must optimize revenue streams without compromising patient care. Administrative burdens add to these challenges.

Medication Therapy Management (MTM) 59

Medication Therapy Management (MTM) Hospitals Documentation Communication 59

Pharmacy Is Right For Me

APRIL 4, 2023

In addition to learning more about unique pathways on-site, you can also understand more about the career paths of these pharmacists here on our blog. Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC).

Hospitals 130

Hospitals Communication Medical Records Dosage 130

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

We note that the other FDA guidance document on nitrosamines addresses NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5 micrograms per day “for any unstudied chemical that poses a negligible risk of carcinogenicity or other toxic effects.”

Documentation 105

Documentation Compounding 105

Pulses

JUNE 6, 2023

It is more helpful for students to individually outline solutions and then get together to work through all the details and compile the final document to submit. Pulses is a scholarly blog supported by Currents in Pharmacy Teaching and Learning

Documentation 105

Documentation Communication 105

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.

Documentation 52

Documentation Drug Development 52