Broad Institute

FEBRUARY 27, 2024

Broad-MIT Seminars in Chemical Biology By Rose Circeo February 27, 2024 Breadcrumb Home Research Broad-MIT Seminars in Chemical Biology MIT Chemistry and the Broad Institute host monthly seminars in chemical biology with the intent to hear from the thought-leaders and bring together chemical biologists from both academia and industry in the Boston/Cambridge (..)

RNA 52

RNA DNA Regulations Disease 52

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Drug Target Review

DECEMBER 5, 2024

2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. Access to fast, high-throughput tools during the manufacturing process will accelerate the development of therapeutics while adhering to regulations and stringent quality standards.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. OPEQ is organized into eight “Offices of Health Technology” (OHTs), which are structured by therapeutic area (e.g.,

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Trials 40