The Knowledge Shelf

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Fagron Compounding Services. Wichita, KS. 483 issued 08/08/2025
FEI Number 3012104093
Firm Name Fagron Compounding Services
Record Type 483
State KS

Erosive Esophagitis: Developing Drugs for Treatment

Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment

Disseminated Coccidioidomycosis: Developing Drugs for Treatment

Withdrawn and Expired Guidances | Drugs

This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver” that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

KEYNOTE SPEAKER – Janet Woodcock MD, Acting Commissioner of FDA

Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants