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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Drug Discovery

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. One notable change in the new draft guidance is the language regarding when a DMC is recommended, reflecting the much broader adoption of DMCs since 2006.

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FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog: Biosimilars

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Informa Connect’s Life Sciences Pricing & Contracting USA

Drug Channels

Listen in as Takeda and Sanofi discuss IRA and AMP Cap Removal and how policy changes and evolving regulations will transform the contracting atmosphere. © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Hear from United Therapeutics and Lundbeck as they discuss synergizing MDRP and SPTR.

Science 98
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Drug Pricing Transparency Congress

Drug Channels

You'll be part of the important discussions on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Copyright © 2006-2022 Pembroke Consulting, Inc. Hybrid Event March 28-29, 2022 | Philadelphia, PA www.informaconnect.com/drug-pricing-transparency.

Drugs 97
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How and Why I Was Overcharged by Penn Medicine and My Blue Cross Health Plan: A True Story (rerun)

Drug Channels

This tale neatly summarizes why so many people hate our healthcare system—and why the average patient will have trouble benefiting from transparency regulations. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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How and Why I Was Overcharged by Penn Medicine and My Blue Cross Health Plan (A True Story)

Drug Channels

This tale neatly summarizes why so many people hate our healthcare system—and why the average patient will have trouble benefiting from transparency regulations. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. to 1:30 p.m. CLICK HERE TO LEARN MORE AND SIGN UP. d/b/a Drug Channels Institute.

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Article Periodic Thank You Commission proposes exemptions to UV-328 ban under POPs Regulation

Agency IQ

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). This exemption is in accordance with Article 4(1)b of the POPs Regulation.