The FDA released final guidance for devicemakers laying out the information it provides when it denies export certificate requests and the steps firms should take to appeal rejections. Source: The…
A drugmaker in the Czech Republic was listed on the EudraGMDP inspection database for serious deficiencies at its Prague facility including the presence of mold and dead insects. Source: Drug…
The FDA rapped drugmakers in China, India and Japan after discovering good manufacturing practice violations at their facilities. Source: Drug GMP Report
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in a draft guidance. Source: Drug…
The FDA issued warning letters to six companies for violations ranging from data integrity deficiencies to selling unapproved products. Source: Drug GMP Report
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Source: Drug GMP Report
In a new draft guideline, the World Health Organization (WHO) offered recommendations on complying with data integrity, GMP documentation and recordkeeping requirements. Source: Drug GMP Report
Novartis has forged a merger agreement with The Medicines Company under which it will buy up the firm’s cholesterol drug inclisiran for a whopping $9.7 billion. Source: Drug Industry Daily
The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product. Source: Drug Industry Daily
In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a…