Lyne Laboratories of Brockton, Mass., was cited for inadequate lab controls in a Jan. 17 warning letter. The firm, a contract manufacturer of oral liquids, powders, semi-solids, tablets and liquid dose unit-dose packaging, was cited for failing to thoroughly review the failure of a batch or any of its components to meet specifications. FDA said the company has not completed an investigation into the chemical composition and potential patient risk for particulate matter found in its Calcitriol Injection. The firm was also cited for failure to establish adequate laboratory controls including scientifically sound and appropriate test procedures to assure that drug product components and drug products conform to appropriate standards of identity, strength, quality and purity
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.