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Informa Connect's Hub and Specialty Pharmacy Models West

Drug Channels

President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S. O’Brien, Pharm.

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Eduardo De La Calle, Director of Regional Supply, AstraZeneca Shefali Shah, Global VP, Market Value and Commercial Effectiveness, MindMaze And more !

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

In connection with this effort, on June 8, 2023, FDA participated in a public workshop on the use of innovative manufacturing technologies and discussed potential barriers to their adoption. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts

FDA Law Blog: Biosimilars

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

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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