Browse Huegel, Kelly

1-18 out of 18 article(s)

Title	Type	Date	Words
While excipients stay low-risk, FDA inspection policy will stay business as usual. (Excipients).		Sep 1, 2002	620
Pharmaceuticals for the 21st century: key points of the initiative.		Aug 1, 2002	368
FDA takes beating from both sides at committee hearing on re-importation; debate focuses on safety. (Counterfeiting/imports).		Jul 1, 2002	834
FDA seeks to provide "clear explanation of expectations" with regard to stability data. (Stability).		Jul 1, 2002	673
Amgen using ISO 9001:2000 for QC/QA; executive sees merits in looking at systems. (Quality systems).		Jun 1, 2002	737
Committee works to create PAT guidance; FDA, industry reps say long-term benefits outweigh potential implementation problems.	Brief Article	May 1, 2002	696
Firms should move to process analytical technology, top CDER official says.	Brief Article	Apr 1, 2002	445
Use of common equipment in tissue-based products concerns FDA; cellular, tissue rules designed to be risk-based.	Brief Article	Apr 1, 2002	510
Scope, intensity of investigations should be dictated by type, source of adverse information.	Brief Article	Apr 1, 2002	880
FDA may rewrite compounding rules 'from scratch'.	Brief Article	Apr 1, 2002	475
FDA, industry struggle to find common ground on impurities, skip testing, other issues. (Specifications).		Mar 1, 2002	1042
Ex-FDA lab director sees no specificity on retests in final OOS guidance.	Brief Article	Feb 1, 2002	831
Nothing new in final guidance, but key clarifications could aid compliance efforts.		Jan 1, 2002	1849
'Data contamination' via software seen causing more FDA oversight; Roche exec cites increased adverse events.	Brief Article	Dec 1, 2001	776
Device validation should be 'stable and capable,' FDAer says.	Brief Article	Dec 1, 2001	621
Culture of compliance originates from top levels of management.	Brief Article	Dec 1, 2001	629
Purdue system has templates, automatic alerts of OOS results.	Brief Article	May 1, 2001	566
Notebook system benefits outweigh FDA reg needs.	Brief Article	May 1, 2001	684