Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Pharmacology Pharmacodynamics Aticaprant is a potent , selective , short-acting (i.e., 2] Aticaprant is taken by mouth. [1]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

JULY 8, 2024

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

FDA Science Regulations Production 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 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

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