FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” Opportunity for feedback from FDA if provided pre-BLA.

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Common Sense Family Doctor

JUNE 8, 2025

In 2024, the New York City Department of Health held a series of workshops on hospital emergency responses to an improvised nuclear detonation by a nonstate terrorist actor. The world is woefully unprepared for the health consequences of the use of a single nuclear device, much less a nuclear war.

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Physician's Weekly

JUNE 13, 2025

Physicians may participate in more traditional community engagement venues such as community health fairs or organizing screenings, providing educational workshops on nutrition exercise and disease prevention or helping facilitate small group chronic disease management.

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Physician's Weekly

JUNE 26, 2025

Created in consultation with emergency medicine professionals, the show aims to raise awareness and provide validation to frontline healthcare workers everywhere. Created in consultation with emergency medicine professionals, the show aims to raise awareness and provide validation to frontline healthcare workers everywhere.

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Maine Academy of Family Physicians

JULY 11, 2024

Doc4aDay is a community outreach program provided through the Maine Medical Center Department of Medical Education. For the past few years, MAFP has provided financial support for this opportunity hoping to encourage young adults in communities under-represented in medicine to become physicians (and hopefully family physicians!).

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FDA Law Blog

SEPTEMBER 16, 2024

In connection with this effort, on June 8, 2023, FDA participated in a public workshop on the use of innovative manufacturing technologies and discussed potential barriers to their adoption. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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FDA Law Blog

JUNE 21, 2021

Sasinowski — On June 17, 2021, FDA gave notice of an upcoming public workshop focused on clinical trial designs for progressive multifocal leukoencephalopathy (PML). The virtual workshop will take place on September 21, 2021, and a public docket seeking comments on the workshop will remain open until November 1, 2021.

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LEAD Physician

SEPTEMBER 19, 2022

The feedback is typically provided through anonymous surveys or interviews. The results provide insights into areas where you need to improve and what you're doing well as a leader. Conferences and workshops can provide valuable information about current trends in business and the latest research on effective leadership practices.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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My Green Doctor

APRIL 4, 2025

The Power of Healthcare Professionals as Trusted Messengers Patients Trust Their Healthcare Providers A recent study found that 64% of physicians recognize environmental sustainability affects their patients’ health, yet only 17% feel comfortable discussing it ( PubMed ). Need help planning an event?

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BMJ

AUGUST 20, 2021

In its best use case, such technology would provide the foundation of person-level digital information systems that can be used to accurately collect and use data in at two critical levels: in real-time to improve individual patient outcomes, and aggregated to monitor the health status of a population, i.e. the big numbers.

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LEAD Physician

SEPTEMBER 26, 2022

Physicians must be leaders in their field to provide excellent patient care, manage a large team and coordinate between departments, and support their patient's overall health with information about prevention and maintenance. Leadership skills are crucial for physicians, who represent one of the most important occupations in our society.

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FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

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FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary sup??

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ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

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FDA Law Blog

MARCH 1, 2023

The lessons learned were also discussed during a November 2022 workshop hosted by the FDA. The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage.

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CDOCS

MARCH 4, 2024

Providing opportunities to learn new skills and advance their careers not only enhances job satisfaction but also improves the patient experience.<br Now is the time to change that! Dental assistants trained in specialized procedures can enable the practice to expand its service offerings. </p>

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FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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FDA Law Blog

DECEMBER 6, 2024

CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. This could occur during an End-of-Phase 2 (EOP2) meeting if a Phase 2 study is expected to provide primary evidence of safety and effectiveness.

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CDOCS

JUNE 3, 2021

<p><span style="font-size:14px;">The Spear Facially Generated Treatment Planning workshop I took early in my career had a massive impact on the amount of comprehensive dentistry I can now see and diagnose and present to my patients. </span></p> <p>[image:Anterior_Case_005.jpg]<br

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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FDA Law Blog

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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FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

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FDA Law Blog

JULY 7, 2022

A flurry of activity followed the 2012 meeting including several workshops organized by the Brookings Institute and the launch of a new (and apparently now abandoned) acronym by FDA: NSURE – Nonprescription Drug Safe Use Regulatory Expansion. Among other things, the applicant would need to include a statement of the necessity of the ACNU.

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GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? But before we do, do you have a song request? I think Kellie, do you have it? Alex: Yeah.

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GeriPal

DECEMBER 2, 2022

Summary Transcript Summary. What would it take to transform dementia care? Alex: We have a full house today. We’re delighted to welcome Judy Long, who’s a palliative care chaplain at UCSF and a caregiver. Judy, welcome to the GeriPal podcast. Judy: Thank you. It’s great to be here. Alex: Great. So take it away. When was that, 2010?

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CDOCS

MARCH 28, 2025

These small composite additions provide essential grip and force application, allowing aligners to move teeth with precision. </span><span Shah, visit our orthodontic course pages and register for a hands on workshop today!<br

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FDA Law Blog

MAY 3, 2022

During the episode, Oliver provides examples of medical devices featured as part of spon-con on local news stations, and demonstrates how his team was able to buy local news time to promote “ the world’s first sexual health blanket.”).

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FDA Law Blog

MARCH 13, 2023

To further expand patient input into product development, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products or “OTP” (formerly the Office of Tissues and Advanced Therapies, or “OTAT”) is holding a free public workshop titled, Clinical Trials: The Patient Experience.

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GeriPal

OCTOBER 12, 2023

Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. And, surgeons often spend the majority of their conversations with patients describing anatomical details and exactly how they plan to ‘fix it’ , with little discussion of what that ‘fix’ will do for a patient’s overall goals.

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FDA Law Blog

JANUARY 23, 2023

The Act provides a lot of detail in what the guidance—and in turn, diversity action plans— should cover. The COVID-19 pandemic temporarily halted many clinical trials and left an indelible mark on clinical trial recruitment. FDA can waive the requirement to submit a diversity action plan on its own initiative or at the request of a sponsor.

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Maine Academy of Family Physicians

OCTOBER 22, 2023

As I am interested in becoming an abortion provider and continuing to be involved with Maine Family Planning throughout my career, this experience was very meaningful. As the Maine delegate, I attended Congress business sessions, participated in resolution writing workshops, and voted for candidates in elections.

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GeriPal

OCTOBER 3, 2024

As BJ MIller writes in the foreword, “ May this book be a portal — a way for us to move beyond the unwise territory of trying to ‘do it right’ and into the transcendent terrain of noticing what we can notice, loving who we love, and letting death — like life –surprise us with its ineffable beauty. I got questions. Thank you, Alex.

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