The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to…
The FDA sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility. Source: The GMP Letter
A European Medicines Agency expert group has raised concerns about notified bodies assessing companion diagnostics. Source: The GMP Letter
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the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in a draft guidance.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