Remove 2025 Remove Biosimilars Remove Therapies
article thumbnail

Article EMA Thank You What we expect European regulators to do in December 2023

Agency IQ

If all changes are accepted, the date of application is set to be January 1, 2025. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting.

article thumbnail

Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

FDA 40
article thumbnail

Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

article thumbnail

Article EMA Thank You What we expect European regulators to do in November 2023

Agency IQ

11/9/2023: Enters into force 11/9/2025: Date of application To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com ). To contact the editor of this resource, please email Chelsey McIntyre ( cmcintyre@agencyiq.com ).

article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

We have tried to sort guidance documents by topic area.

FDA 40
article thumbnail

Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.