Fierce BioTech

FEBRUARY 6, 2024

This webinar will highlight how top health systems are tackling these ubiquitous challenges and the steps they’ve taken to innovate across the care continuum. png Listing Introduction This webinar will be sponsored and moderated by Biofourmis. The bottom line is suffering. Click here to login.

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Fierce BioTech

MARCH 29, 2024

Listing Image Inovalon Logo.png Listing Introduction Pharmacists are being called to operate at the top of their license to close gaps in care. Is your pharmacy ready to make the leap? Click here to login. Learn how your pharmacy can prepare today for a future of pharmacy focused on patient outcomes.

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The Pharma Data

MARCH 5, 2021

To access the webinar, please go to the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webinar will be available following the presentation. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. About Biogen. Source link:[link].

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 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. 11] Jeffrey N.

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The Pharma Data

JANUARY 19, 2021

CSE: BHSC) (the “Company” or “BioHarvest”) invites its shareholders and the general public to join a Live Video Conference (“Webinar”) on Thursday, January 21st, 2021 at 2:00 PM Eastern Standard Time (11:00 AM Pacific Standard Time). . – January 20, 2021) – BioHarvest Sciences Inc.

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DrugBank

MARCH 15, 2023

The moment you decide which DrugBank license or products best suit your needs isn’t the final step in our relationship, it is just the beginning. Depending on your unique needs, license*, and project goals, you might interact with all of them firsthand, or you might be off and running with just a little help from one team.

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Agency IQ

JULY 22, 2024

However, it does not explicitly address how it might affect products like companion diagnostics (CDx, or IVDs intended to ensure safe use of specific therapeutics) or the regulatory landscape of non-licensed tests used in the course of clinical trials by drug developers.

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The Pharma Data

DECEMBER 15, 2020

Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. KOL Webinar Information BioLineRx will host a KOL webinar today, December 16, 2020 at 8:00 a.m. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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The Pharma Data

JANUARY 27, 2021

This webinar will give current and prospective investors a clear vision of the Company’s goals for 2021 and beyond. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.

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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. MHRA also offered an online webinar to learn more about the pathway and public involvement.

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Agency IQ

JUNE 2, 2023

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

DECEMBER 12, 2020

Webinar and conference call. A webinar and conference call for investors and analysts will begin at 2:00 pm UK time today, please join 10-15 minutes prior to the scheduled start time. Webinar ID: 995 4603 8702. The combination represents a significant step in AstraZeneca’s strategic and financial-growth plans.

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Agency IQ

JANUARY 12, 2024

The regulator is also working on an Innovative Device Access Pathway (IDAP) that mirrors the pathway already in place for drugs (the Innovative Licensing Access Pathway, or ILAP). Canada, Japan, Brazil and Australia. Read AgencyIQ’s complete history and analysis of the lead-up to the proposed medical device regulations here.]

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Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. To get an approved NDA or Biologics License Application (BLA) you must conduct all phases of clinical studies. A: Yes, the EUA is just temporary. Then you can submit an application for approval.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

SEPTEMBER 29, 2023

The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

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Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” The MHRA is holding a webinar on the new pathway from 11am to 12pm BST on September 14. market more quickly.

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Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.

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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 following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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Drug Channels

MARCH 18, 2025

Pharmacies and PBMs, Examining $683 Billion Market Review pricing/license options and download the full 2025 report Order before March 31, 2025 to receive special discounted pricing! Want to bundle the report with DCIs video webinars ? Note: All license versions include exhibits within the text.) Didnt get it?

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FDA Law Blog: Biosimilars

DECEMBER 3, 2024

Indeed, in a recent Federalist Society-sponsored webinar, titled “ Does Jarkesy Doom the Preserve Access to Affordable Generics and Biosimilars Act? ,” moderator Brian Pandya (Duane Morris LLP) hashes out the interplay between Jarkesy and The Preserve Access to Affordable Generics and Biosimilars Act with Matthew S.

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Drug & Device Law

JANUARY 21, 2024

EST. The webinar will provide further insight and analysis on the cases featured in our posts on the worst decisions and best decisions of the past year. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed.

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Drug & Device Law

JANUARY 6, 2024

As we do each year, we’re pleased to announce that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2023” on Thursday, January 25th at 12 p.m.

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Drug & Device Law

NOVEMBER 4, 2023

Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. All other webinars are presumptively approved for 1.0 All other webinars are presumptively approved for 1.0 Please allow 4-6 weeks for CLE processing.

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Drug & Device Law

JANUARY 7, 2023

As we do each year, we’re pleased to announce that three of your bloggers – Bexis, Steven Boranian, and Rachel Weil – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2022” on Thursday, January 19 th at 1 p.m. This program is presumptively approved for 1.5

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Drug & Device Law

NOVEMBER 5, 2022

You can register for the webinars here.). You can register for any of the webinars by clicking here. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Each remaining webinar is presumptively approved for 1.0

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Drug & Device Law

JANUARY 15, 2022

As we have done for a number of years, now, we are delighted to announce that we will be presenting a free 90 minute CLE webinar on “The good, the bad, and the ugly: The Best and Worst Prescription Drug/Medical Device Decisions of 2021” Friday, January 21 at 12:30 PM ET.

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