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May 08, 2023
FDA’s Division of Applied Regulatory Science’s (DARS) computational toxicology and pharmacology research has been focused on the development of highly curated data sets and QSAR models for endpoints of regulatory interest.
April 18, 2023
Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.
January 23, 2023
The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.
January 11, 2023
This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.
A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.
December 13, 2022
The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.
October 02, 2022
There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.
September 16, 2022
Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.
September 02, 2022
While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.
August 02, 2022
Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.