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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. Join us in New Orleans on May 21-23 where you’ll gain critical insight into regulatory requirements, policy initiatives and best practices to enhance pricing and contracting models.

Science 98
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FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

With extensive experience in manufacturing techniques and regulations, the CMC services team at Premier Consulting can help sponsors navigate the development of advanced manufacturing technologies. Contact us today to find out how we can support your program.

FDA 52
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Informa Connect’s Medicaid Drug Rebate Program (MDRP) Summit

Drug Channels

MDRP 2022 is your chance to hear directly from the government regulators creating the rules, the industry leaders interpreting them and the manufacturer experts implementing them – You won’t want to miss it!

Drugs 75
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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40
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HP&M’s Faraz Siddiqui to Speak at Informa’s Medicaid Drug Rebate Program (MDRP) Summit 2023 on Value Based Programs

FDA Law Blog: Biosimilars

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. Hyman, Phelps & McNamara, P.C.’s s Faraz Siddiqui will speak on Tuesday, September 19, on Value-Based Agreements.

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Power to the Patient with Patient Generated Health Data

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans.