FDA Law Blog

AUGUST 23, 2021

PhRMA has updated its guidance regarding speaker programs through the following additions to the Code: The purpose of a speaker program should be to present substantive educational information to address a bona fide educational need, and only those with a bona fide educational need for the information should be invited (i.e.,

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pharmaphorum

MAY 25, 2022

Despite this update, activities such as funding medical education, providing sponsorship to medical society-led events, hiring exhibition space, and supporting speakers are still covered by Article 7 of the IFPMA Code, Article 10 of the EFPIA Code, and Articles 4, 5, and 7 of the PhRMA Code. End of the host country. About the author.

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pharmaphorum

NOVEMBER 23, 2020

German digital health company smartpatient is adding a new section of its MyTherapy app providing information on wet age-related macular degeneration (AMD), a leading cause of blindness.

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FDA Law Blog

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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FDA Law Blog

DECEMBER 8, 2022

Under Section 201(qq) of the FDC Act, “major food allergens” include milk, eggs, peanuts, wheat, soybeans, fish, shellfish, tree nuts, and effective Jan. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023, sesame. lampreys); Bony fish (e.g., trout); and.

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Cloudbyz

FEBRUARY 8, 2021

Read through the About Us section to get a sense of the company values and culture and how they take on the business. The case studies and client testimonials are other sections that give a hint of social proof and help you understand if you will benefit from partnering with the vendor. Check for service and support.

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Cloudbyz

FEBRUARY 5, 2021

Read through the About Us section to get a sense of the company values and culture and how they take on the business. The case studies and client testimonials are other sections that give a hint of social proof and help you understand if you will benefit from partnering with the vendor. Check for service and support.

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FDA Law Blog

OCTOBER 19, 2021

If you haven’t heard of the Penalty Offense Authority found in Section 5 of the FTC Act, 15 U.S.C. § This would dramatically improve the FTC’s effectiveness relative to our current approach, which relies almost entirely on another authority, Section 13(b). Rohit Chopra & Samuel A.A. forthcoming). Chopra & Levine , supra.

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ACRP blog

JANUARY 3, 2024

Education Level and Socioeconomic Status: When individuals in lower socioeconomic brackets are excluded from trial participation, researchers cannot fully understand how treatments affect underrepresented cross-sections of society.

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pharmaphorum

SEPTEMBER 29, 2022

Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the FD&C Act.

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Cloudbyz

FEBRUARY 8, 2021

Read through the ‘About Us’ section to get a sense of the company values and culture and how they take on the business. The case studies and client testimonials are other sections that give a hint of social proof and help you understand if you will benefit from partnering with the vendor. Check for service and support .

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FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA recently shared some statistics on the impact of ASCA during the FDA Small Business Regulatory Education for Industry (REdI) Annual Conference held on June 5-9, 2023.

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XTalks

DECEMBER 7, 2023

On November 30, the US Food and Drug Administration (FDA) unveiled new resources and Frequently Asked Questions (FAQs) to further educate stakeholders about the Food Traceability Rule under FSMA 204. The rule, a key element of the FDA’s New Era of Smarter Food Safety Blueprint, implements Section 204(d) of the FDA FSMA.

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pharmaphorum

JANUARY 31, 2023

Adherence and education solutions – the glue between patient and pharma In order to restore trust in the pharmaceutical industry, individual companies must invest in solutions that address the patient’s overall health – proving care is extended beyond the business interests of pharmaceutical companies.

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pharmaphorum

JULY 12, 2022

Effective self-management also places less burden on healthcare systems, as demonstrated in a 2018 cross-sectional analysis of electronic health records. Thanks in part to digital transformation, people can now expect to receive patient portal invitations, adherence reminders, and even disease education along with a new prescription.

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Sciensano

OCTOBER 9, 2023

All initiatives are described in detail in the official action plan which was recently published by the Department ‘Omgeving’, section ‘Animal Welfare’. Last July, a series of educational webinars focussing on the development of alternative methods was launched with already two webinars being organised.

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XTalks

NOVEMBER 8, 2023

Renowned for its comprehensive portfolio of food and beverage products, Nestlé has a significant food service operation serving various clients, including educational institutions and cruise lines. In a conversation with CNBC , Lore highlighted the importance of the Nestlé collaboration in accelerating Wonder Group’s growth.

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Pfizer

JANUARY 26, 2023

For that reason, this week, we are commemorating Juneteenth by educating our colleagues about the historical and cultural significance of the day, while renewing our commitment to our Equity Value – Every person deserves to be seen, heard, and cared for. Congress the power “to enforce this article by appropriate legislation.” [3]

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The Pharma Data

NOVEMBER 18, 2020

Gender Section of UN Human Rights. contraception. , comprehensive sexuality education. Comprehensive sexuality education (episode 1 of 4) . Building support and understanding of every young person’s right to education, health and well-being, in an inclusive and gender equal society. . . sustainable development.” . “The

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Roots Analysis

MARCH 14, 2023

Presently, a number of players offer different patient retention services, such as study-branded gifts and reminders, education and support materials, reimbursement programs, transportation programs, patient engagement websites, patient reconnect programs and mobile applications.

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XTalks

MAY 11, 2023

I worked for several years at the Canadian Hearing Society, an industry-leading provider of services, products and education that empowers individuals in the deaf and hard of hearing communities to overcome barriers to participation. This can include cutting out sections that are not relevant, adding transitions and color correction.

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Pfizer

FEBRUARY 1, 2023

The “As We Age” section of the site includes resources, education, and encouragement for older people with cancer and their caregivers, who often face mental health struggles and other life stresses beyond cancer itself. “If A one-size-fits-all approach isn’t enough.

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FDA Law Blog

JULY 7, 2021

The only place in the country that uses GEDs for SIB/AB is the Judge Rotenberg Educational Center in Massachusetts (JRC), and the patients it treats suffer from severe behaviors, such as head-banging or self-biting, that have not been resolved using conventional treatments.

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ACRP blog

AUGUST 1, 2023

We are grateful for the input we received from so many ACRP volunteers to provide an authentic ‘voice of the clinical research professional’ in the comments submitted to the FDA,” said Bridget Gonzales, CCRC, Head of Educational Programs and Customer Success for ACRP.

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ACRP blog

AUGUST 1, 2023

We are grateful for the input we received from so many ACRP volunteers to provide an authentic ‘voice of the clinical research professional’ in the comments submitted to the FDA,” said Bridget Gonzales, CCRC, Head of Educational Programs and Customer Success for ACRP.

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pharmaphorum

SEPTEMBER 27, 2021

As the vaccines were developed and rolled out, the disparity in their take up among different sections of the community highlighted how excluded some minority communities felt from areas of healthcare. And then the COVID-19 pandemic really brought it into sharp relief.

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WCG Clinical

JULY 17, 2023

Uncharted Territory for Patients The WCG Avoca survey revealed that 75% of patient respondents (who represent a cross section of the US population), have no direct relationship to a trial. So, how do we leverage that data and that experience to help educate research-naïve patients?

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WCG Clinical

DECEMBER 13, 2023

These supplements are not classified as drugs under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and, as such, do not require pre-marketing approval from the U.S. Dietary supplements are easily accessible on store shelves or online marketplaces. Food and Drug Administration (FDA).

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pharmaphorum

OCTOBER 13, 2020

The report covers three sections: The Innovation Landscape, Financing Innovation and Sustainable Innovation. The report reveals that R&D departments are being empowered by the creation of ‘innovation ecosystems’, new funding methods, and the deployment of technology. Yet these emerging trends seem chiefly driven by private resources.

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FDA Law Blog

JULY 10, 2023

The most common type is the Traditional 510(k), therefore this section summarizes the timeline of the FDA review process for a Traditional 510(k). 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. an administrative appeal) under 21 CFR 10.75

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pharmaphorum

JULY 6, 2022

A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a median of 241 days. Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. About the author.

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FDA Law Blog

DECEMBER 22, 2022

Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections. One of the more concerning provisions in the Appropriations Bill can be found in section 3306, which addresses “Bans of Devices for One or More Intended Uses.”

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pharmaphorum

MARCH 15, 2022

On the pro side, the advantages are not too surprising, with the stated educational equivalence or superiority supporting the trend towards doctors’ preferences for online CME. Effective medical-education techniques. Figure 1 What doctors say about virtual events . . Digital security. User experience design. Design thinking.

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pharmaphorum

MAY 9, 2022

Users receive rewards in a section of the app called My Spot, which resembles a campground. In addition to a rewards-based system, users are allotted tools that can help tackle symptoms of depression via education and skill-building.

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Pharmacy Checkers

FEBRUARY 7, 2020

Instead, they choose to spend their time “educating” the public about the dangers of prescription drug importation, warning Americans that it’s not safe to buy lower-cost medicines from other countries over the Internet. pharmacies. They have even included PharmacyChecker.com and this very blog (!)

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The Pharma Data

MARCH 8, 2022

Sanofi communicates on a quarterly basis on the progress on implementation of its social impact strategy with a dedicated section in the earnings press release. The continuous implementation of Sanofi’s social impact strategy has led in recent months to a range of positive updates of the company’s rank or grade in most of the ESG rankings.

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The Pharma Data

SEPTEMBER 10, 2020

New educational effort provides key resources to patients and healthcare providers at a time when more than two-thirds of Americans surveyed in a recent Harris Poll have delayed healthcare due to the COVID-19 pandemic [1]. My Health Can’t Wait is an important effort to educate patients and encourage them to seek treatment they may need.

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