Remove 2029 Remove Drugs Remove Regulations Remove Trials
article thumbnail

Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Agency IQ

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

article thumbnail

Diabetic eye disease: The urgent need for early, non-invasive treatments

Drug Discovery World

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. million by 2029, according to GlobalData. Pazopanib eye drops: a randomised trial in neovascular age-related macular degeneration. In 2019 there were >14.2 Br J Clin Pharmacol. 2019;85(2):347-355.

Disease 162
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. Once the E.U.

article thumbnail

Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

FDA 40
article thumbnail

The politics of health: How 2024 elections will impact life sciences

Drug Discovery World

This, coupled with looming patent expirations, the impact of new drug pricing regulations, and tighter universal regulation of medical devices presents a complex environment for both large and small life science companies. Despite criticising the IRA in the past, Trump is also prioritising a reduction in drug costs.

Science 130