Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

MAY 31, 2024

Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). 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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. 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

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

MAY 3, 2024

Many of these are webinars and/or trainings sessionsfor new digital platforms. 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. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. Prohaska, Kavita C.

FDA 40

FDA Science Regulations Production 40