Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

Agency IQ

JULY 28, 2023

This assessment is due to be published for public comment by June 30, 2025 , will a public meeting to be held by September 30, 2025 “to discuss the report, its findings, and the Agency’s specific plans to address the report recommendations.” Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Alta Sciences

MARCH 27, 2025

Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category pmjackson Thu, 03/27/2025 - 19:42 Laval, Qubec, March 27, 2025 Altasciences , a nine-time CRO Leadership Award winner, is proud to announce they have been awarded a 2025 CDMO Leadership Award in the Small Molecule Dosage FormNorth America category.

Small Molecule 40

Small Molecule Clinical Pharmacology Drug Development Pharmaceuticals 40

Drug Target Review

NOVEMBER 27, 2024

For example, the European Medicines Agency (EMA), in its Regulatory Science Strategy to 2025 , has highlighted the critical role of biomarker discovery, qualification and utilisation in accelerating precision medicine. Clinical Pharmacology & Therapeutics. Available from: [link] Bakker E, Hendrikse NM, Ehmann F, et al.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

New Drug Approvals

APRIL 18, 2025

January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. Article ] Rosati G: Clinical pharmacology of iomeprol. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024. ^ New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report).

Production 52

Production FDA FDA Approval Clinical Pharmacology 52

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2] Acoramidis was authorized for medical use in the European Union in February 2025. [2] 11 February 2025. Retrieved 16 February 2025. January 2025. 26 November 2024.

FDA Approval 62

FDA Approval FDA Production Treatment 62

Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

Regulations 40

Regulations FDA Science Production 40