Agency IQ

OCTOBER 20, 2023

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. Pharmacodynamic (PD) alternatives: Another internal project, this time from CDER’s Office of Clinical Pharmacology (OCP), was presented by YOW-MING WANG, associate director.

Science

Alta Sciences

MAY 15, 2023

Integrated Clinical Sites Accelerate Timelines Well-suited and qualified clinical pharmacology units (CPUs) for early phase trials are getting more expensive to run due to the growing complexity of required clinical procedures, and the precision around participants to be recruited. Altasciences has U.S.

Drug Development

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars

Agency IQ

DECEMBER 11, 2023

The data used to generate a control arm may be derived from prior clinical trial data (individual or pooled), or observational, real-world data (RWD), such as from registries, electronic health records (EHRs), and medical or pharmacy claims.

FDA

Agency IQ

JUNE 16, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations

Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

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

Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA