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|December 17, 2015
FDA Releases IND Safety Assessment Guidance
Author(s)Pharmaceutical Technology Editors
The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.
Advertisement
FDA has published
The guidance, which is applicable to sponsors managing a drug-development program, offers recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations at § 312.32 (21 Code of Federal Regulations 312.32). Specifically, the guidance recommends “the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned un-blinding of safety data, reporting thresholds for IND safety reporting, and the development of a safety surveillance plan.”
Source:
Advertisement
Related to this article
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
The FDA has approved remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
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.
Advertisement
Advertisement