PharmaFab Revising Standard Operating Procedures After FDA Warning Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
The company modifies its processes for batch reprocessing, stability testing and purified water handling after FDA cites production shortcomings. The Texas facility produces tablet, capsules and liquid cough and cold products.
You may also be interested in...
Italy Leads European Push Into Conditional Reimbursement
Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.
Changes To The NHS: How Can Pharma Best Position Itself?
The U.K.’s Health and Social Care Bill was introduced into Parliament on Jan. 19, offering a new commercial landscape best navigated by pharma through bolstered relationships with general practitioners.
Lilly Funding Study Of Corcept's Corlux For Mitigation Of Zyprexa Weight Gain
Companies will share data from the proof-of-concept study, but they do not intend to commercially pursue the use of both drugs in combination.