Agency IQ

OCTOBER 27, 2023

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?

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program.

Science 40

Science Biosimilars FDA Production 40

FDA Law Blog: Biosimilars

JANUARY 11, 2024

This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of doing business in Puerto Rico. HPM is a co-sponsor of the event.

Pharmaceuticals 59

Pharmaceuticals Compliance Licensing Licensing 59

Agency IQ

AUGUST 2, 2024

Start Date End Date Event Event Type Organization 8/5/2024 8/8/2024 PRAC August meeting Committee Meeting ( CLOSED ) Pharmacovigilance Risk Assessment Committee (PRAC) 8/6/2024 8/6/2024 Infectious Diseases Working Party Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 08/12/2024 5 weeks Explore innovative personalized therapeutic (..)

Regulations 40

Regulations Clinical Trials Production International 40

Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

Regulations 40

Regulations Pharmaceuticals Production Compliance 40

Agency IQ

MAY 3, 2024

Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

DECEMBER 1, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

FDA 40

FDA Science Regulations Production 40