Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|August 18, 2020
Developing Drugs to Treat Acute Myeloid Leukemia
Author(s)Pharmaceutical Technology Editors
FDA published guidance regarding the development of treatments for acute myeloid leukemia.
Advertisement
FDA published
The guidance document discusses different patient populations including pediatric patients, patients with organ impairment, older patients, and pregnant patients. Efficacy endpoints, exploratory trial considerations, and confirmatory trial considerations are addressed. The guidance also addresses regulatory submissions.
Source:
Advertisement
Related to this article
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Advertisement
Advertisement