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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post.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

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The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). In such cases, performance testing may be conducted again.

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FDA Law Blog: Biosimilars

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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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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PharmD Live

JANUARY 22, 2025

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. PharmD Live supports retention by: Improving communication to build trust. To stay viable, physicians must optimize revenue streams without compromising patient care.

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Pulses

SEPTEMBER 26, 2023

This shift highlights the significance of effective communication, teamwork, and adaptability. Despite the challenge of quantifying these skills, their influence on a student’s ability to cultivate professional relationships, effectively communicate, and collaborate in a team cannot be overstated. teacher), entertainment (ex.

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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. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. These steps can significantly reduce errors, improve overall compliance, and ensure responsible stewardship of public funds.

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Insurance Coverage and Processing Documentation Hospitals Communication 52

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). But this year, enforcement is particularly lull.

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Pulses

JUNE 6, 2023

This helps them to connect even outside the classroom to communicate about questions they may have and creates a stronger support system. 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.

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FDA Law Blog: Biosimilars

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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Communication Documentation Biosimilars 53

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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FDA Law Blog: Biosimilars

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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Putting Patients First Blog

APRIL 8, 2025

Sponsors must also communicate how patient data are collected, processed, and used throughout the AI lifecycle, ensuring transparency and maintaining public confidence. 56 ,57 ,58 Finally, comprehensive documentation is essential for reproducibility and public confidence. Strong privacy protections are also essential.

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Eye on FDA

APRIL 17, 2020

” In a subsequent blog posting this month, it was noted that FDA was devoting personnel to focus on COVID-19-related review efforts and that it was certainly possible that this might be a factor in delaying new approvals of non-COVID-19 medicines and devices. But the communication from FDA underscores the possibility.

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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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FDA Law Blog: Biosimilars

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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Putting Patients First Blog

JANUARY 22, 2024

However, content must be presented in a clear and easily accessible way using plain language that is easy to understand and effectively communicated. There are customizable health literacy checks content developers can include when reviewing their documents. Other Blogs: What is Health Literacy and Why is it Important?

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National Association of Boards of Pharmacy

JULY 19, 2024

So, what does this all mean for DSCSA implementation for the dispenser community? In this blog, we will explore questions around what dispensers are still responsible for within DSCSA, what they are actually exempt from, and how they can go about determining if they are exempt.

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Express Pharma

JUNE 20, 2023

Institutional support, such as expert consultants, essential document templates, and protocols for regulatory submissions, is also vital. Finally, public engagement in research has to be sought through informal group sessions communicating the purpose of the human research in plain language.

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FDA Law Blog: Biosimilars

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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Pharmacy Joe

SEPTEMBER 6, 2023

In the first year after implementation over 2000 results were called to the pharmacy and about one-third resulted in the pharmacist ordering an antimicrobial.

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Pharmacy Joe

SEPTEMBER 6, 2023

In the first year after implementation over 2000 results were called to the pharmacy and about one-third resulted in the pharmacist ordering an antimicrobial.

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Pharmacy Technician Communication Inpatient Documentation 52

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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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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FDA Law Blog: Biosimilars

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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Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

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Syner-G

MAY 4, 2022

As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation. Image courtesy of qimono at pixabay.com.

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Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

OCTOBER 3, 2024

Third, it promotes appropriate transparency and accountability in our individual and collaborative efforts, encouraging open communication to enhance accountability and reduce conflicts of interest. Consensus Framework document here. Other Blogs: U.S. health system. Read the U.S. Calloway, Dr. Omar A.

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The Happy PharmD

JANUARY 18, 2023

Apply the power of job crafting to create a new job after communicating your strategy for solving a problem in the firm. Doing so will help you properly document your milestones in your resume and mention them during the interviews, even if you do not want to be on Linkedin or network. Recap all you have accomplished in the past year.

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epicur

AUGUST 8, 2023

Some of the biggest changes that GFI #256 brings include: Increased documentation for patient-specific prescriptions Limitations to available 503A office-stock drugs Although veterinary professionals were aware of the impending changes with GFI for months, many have been left scrambling since it went into effect in April. Read our blog!

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pharmacy mentor

JUNE 17, 2024

If you haven’t already, check out our previous blog that covers all the ways your pharmacy can benefit from using ChatGPT: [link] KEY REMINDER : When you’re using ChatGPT, you must use the most clear and direct prompts possible to ensure you get the most accurate results. ChatGPT is clever… but it’s not a mind reader!

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Ramblings of a pharmacist

SEPTEMBER 26, 2023

As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. The communications I have seen and heard from the big 3 to small dispensers are irresponsible and seem like attempts to sabotage compliance, in my view.

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Pharmacy Joe

NOVEMBER 17, 2021

Both the prescriber and pharmacist were required to document the source of the patient’s U-500 insulin dose in the electronic record, as well as which device the patient used to draw their U-500 insulin dose at home (U-100 insulin syringe, TB syringes, etc).

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