Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.

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pharmaphorum

OCTOBER 7, 2021

If there’s one take-home message about working during a pandemic, it is the enormous value that virtual events, webinars and e-learning can bring when face-to-face meetings and presentations are impossible. The main advantage of webinars and other online interactions is pretty obvious.

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Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. Click here to see the original post from September 2023. Here’s the press release: CVS Health Launches Cordavis.

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Pharma Marketing Network

MARCH 18, 2025

Conversion Rate: Tracks how many users complete a desired action, such as signing up for a webinar or downloading whitepapers. Avoiding misleading claims or unapproved off-label promotions. Offer incentives like exclusive research reports or webinar invites.

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Safe Biologics

NOVEMBER 12, 2023

View the full webinar here or watch individual segments linked below. View ASBM’s recent webinar on the IRA’s effects here. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. ASBM surveys of U.S. Read the full op-ed here. Read it here.

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Big Molecule Watch

SEPTEMBER 7, 2023

Topics that will be covered include the 271(e) Safe Harbor, peremptory challenges, labelling and timing considerations, and competitive intelligence. Click here to register for the webinar. Developing and successfully commercializing a biosimilar is a complex and expensive process.

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pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

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Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Watch clips from the webinar here.

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pharmaphorum

OCTOBER 27, 2022

Webinars – Webinars, whether live streamed or on-demand, can be used for communication with HCPs, HCOs, and POs. A company is responsible for the content of webinars and should take reasonable steps to ensure the audience is targeted and well defined.

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InCrowd

JULY 17, 2024

In Apollo’s recent webinar , moderated by Glenna Crooks, Ph.D. Traditionally reliant on established methodologies, HEOR is now rapidly incorporating RWD and Real-World Evidence (RWE) to support label expansions and integrate with conventional research activities. For more context and a complete discussion, watch the webinar today.

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Safe Biologics

JUNE 6, 2024

These include a webinar featuring an analysis of the policy by former government health officials responsible for developing and implementing Medicare’s prescription drug benefit, a podcast episode, a research paper, a fact sheet, and a patient-education microsite. Read more about the FDA approvals here.

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Pharma Marketing Network

FEBRUARY 19, 2025

Drug names and indications must align with FDA-approved labeling. signing up for a webinar, downloading a whitepaper)? FDA and Fair Balance Messaging All promotional emails must include fair balance messaging benefits and risks must be presented equally. No personal health information (PHI) can be used for targeting or personalization.

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Eye on FDA

JULY 7, 2020

The interesting thing in connection with that is that in May – in the midst of the COVID-19 pandemic – FDA held a Webinar on the “ Bad Ad” Program – a program that deputizes healthcare professionals to assess promotional communications and report potential violations to the agency.

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RX Note

MARCH 28, 2023

Never before, online webinar is so common. To illustrate, every now and then, I may encounter an off-label indication of medication that I do not know of. Learning Undeniably, COVID-19 has evolved the method of healthcare professionals having continuous professional development.

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Putting Patients First Blog

JULY 2, 2024

Clarify What Information is Sought from Speakers Report on Data Utilization Host Educational Webinars Before Listening Sessions Market as Stakeholder Listening Sessions if They Have Broader Representation Improve the Structure of the Listening Sessions. Finally, we encourage CMS to consider a longer time horizon for the submission of data.

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FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.

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Big Molecule Watch

AUGUST 25, 2023

In anticipation of this announcement, below is a recap of the IRA’s Drug Price Negotiation Program and pending legal challenges to various aspects of the program.

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Safe Biologics

MAY 10, 2024

CMS is currently working to set prices for 10 drugs, with the final prices set to be announced by Sept. 1 and go into effect in 2026. Without a change, the number of eligible drugs will increase to 15 in 2027 and 2028 and to 20 every year thereafter.

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Birth Control Pharmacist

MARCH 29, 2021

I recently had the opportunity to attend the Sex & Gender 101 webinar designed to help anyone in the healthcare field learn more about creating trans inclusive care. The term nonbinary is a specific gender identity label and an umbrella term.

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Safe Biologics

APRIL 10, 2023

Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Read the letter declining to exercise march-in rights in the case of Xtandi (enzalutamide) here. Read it Here.

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Drug Channels

DECEMBER 9, 2024

This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. Click here to see the original post.

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Express Pharma

JANUARY 15, 2025

As the industry continues to grow, prioritising product quality, safety, and accurate labelling has become essential. Vitafoods India 2025 brings a host of exciting new features, including a Webinar on “Is the Nutraceuticals Industry Gaining Renewed Immunity with Sustainability?” In India, a nation of 1.4

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FDA Law Blog: Biosimilars

JANUARY 2, 2025

Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat. FDA also plans to host a stakeholder webinar on the final rule at a later date. The final rule does not limit this exemption to only raw fruits and vegetables.

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Pharma Marketing Network

MARCH 18, 2025

Being aware of pharmaceutical advertising laws, fair balance requirements, and off-label promotion restrictions will prevent costly compliance mistakes. Combining HCP webinars, digital advertising, and interactive medical content enhances outreach effectiveness. Organizations like the FDA (U.S.),

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Labeling Labeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A

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Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. The materials from this webinar are still available on FDAs website ( here ). Since the new administration took office, however, the webinar page has been taken down from FDAs website.

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