Drug Channels

DECEMBER 17, 2020

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. As you will see below, Dr. Gottlieb was right.

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Drug Channels

NOVEMBER 15, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2022. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. The Outlook 2022 marks our third annual outlook webinar. Broadcast live on December 17, 2021.

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Drug Channels

MARCH 30, 2023

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version.

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Drug Channels

APRIL 3, 2024

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. The 2024 formularies described below should boost biosimilar adoption. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

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Drug Channels

MAY 29, 2024

Register now for The 340B Drug Pricing Program: Trends, Controversies, and Outlook , a new live video webinar with Adam J. Join my nearly 56,000 LinkedIn followers for daily links to neat stuff. Click here to learn more and reserve your spot at the June 21 event.

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Drug Channels

NOVEMBER 29, 2022

In this issue: Mark Cuban schools Elon Musk on PBMs Market access lessons from Semglee Gen Z rejects the pharmacy career path A potent call for 340B transparency Plus, get ready to love the ‘90s again! Please join me for my upcoming live video webinar, Drug Channels Outlook 2023 , on December 16, 2022, from 12:00 p.m. to 1:30 p.m.

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Download your copy today. In this complimentary webinar , Mel B. Watch the webinar.

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

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Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. Some “add-on” regulatory data protection may also be converted to market exclusivity.

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Agency IQ

MAY 3, 2024

Many of these are webinars and/or trainings sessionsfor new digital platforms. This month will also see several large, multi-day conferences hosted by public and private stakeholders. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No.

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Agency IQ

MAY 31, 2024

Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries.

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Agency IQ

MARCH 29, 2024

This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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Agency IQ

AUGUST 2, 2024

Major European regulators, national competent authorities, and interest groups are planning on hosting several webinars and trainings throughout August and September. Speaking of policy, legislative affairs will also likely pick up.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. 20, 2023) (“The lack of an equivalent IVD on the market is the primary reason labs develop LDTs.”) [7] PRIA. These fees, however, do not cover all costs. 31, 2023), [link].

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Drug Channels

DECEMBER 1, 2020

Pharmacy and healthcare provider markets experienced unprecedented volatility. Speaking of next year, Drug Channels Institute will host an exclusive live webinar, Drug Channels Outlook 2021 , on December 18, 2020, from 12:00 p.m. During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives.

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FDA Law Blog: Biosimilars

DECEMBER 21, 2023

In an interview with the Blog , FDLI wants to recognize the efforts of Chris Perkins, Gabe Lindman and Emma Dardis of Washington, DC-based marketing agency Model B, for their amazing work. Plus, the burgundy was kicked up a notch to a cherry red.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. market more quickly. The procedure is available for E.U.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

the drug and device) of the combination product.

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FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Having a clear understanding of FDA’s data expectations for 510(k) applications related to implants is crucial for successful marketing clearance. Implant devices are used in a range of settings such as dental and orthopedic procedures.

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Agency IQ

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

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Agency IQ

DECEMBER 1, 2023

Prohaska, Kavita C. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices.

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Drug Channels

APRIL 1, 2025

This week, Im rerunning some popular posts while I prepare for Fridays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace. What do you think?

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Drug Channels

APRIL 3, 2025

This week, Im rerunning some popular posts while I prepare for tomorrows live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Outline the market access implications for provider-administered biosimilars in the buy-and-bill market. Click here to see the original post from February 2025.

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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. The Humira biosimilar market just took another step forwardbut remains far from its ideal state.

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Drug Channels

FEBRUARY 4, 2025

ICYMI, the largest three pharmaceutical wholesalersCardinal Health, Cencora, and McKessonare using vertical integration to build significant market positions in businesses beyond drug distribution. Outline the market access implications for provider-administered biosimilars in the buy-and-bill market.

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FDA Law Blog: Biosimilars

JANUARY 2, 2025

FDA also plans to host a stakeholder webinar on the final rule at a later date. Recognizing that the final rule redefining the term healthy is a significant change from FDAs previous approach (in effect for thirty years), FDA plans to issue guidance documents intended to help industry understand the rule and how to work with FGEs.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). Details of model development should also be provided in a marketing submission.

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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

Judge Jordan asked ACLA for confirmation that he understood correctly that pre-market submission was the major burden for labs and that while pre-market submission compliance dates are still several years away, labs should be preparing now to meet FDAs pre-market expectations. ACLA, of course, confirmed that was true.

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