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

AUGUST 2, 2024

Major European regulators, national competent authorities, and interest groups are planning on hosting several webinars and trainings throughout August and September. Speaking of policy, legislative affairs will also likely pick up.

Regulations 40

Regulations Clinical Trials Production International 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

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

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)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

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40