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

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

AUGUST 2, 2024

For example, on July 25, the Hungarian presidency hosted an informal meeting of health ministers to discuss health issues, such as mitigating the effect of cardiovascular diseases and implementing the European Health Data Space (EHDS).

Regulations 40

Regulations Clinical Trials Production Trials 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. Adeno-associated virus as a delivery vector for gene therapy of human diseases. Adeno-associated virus-based gene therapy for lifelong correction of genetic disease. 2024;9(1):78.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Taking a closer look, nearly half of the products were reviewed by the Office of Oncologic Diseases. Data on these novel approvals is published throughout the year by both CDER and CBER. What’s next? Stay tuned.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. 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