Devices

Letter Gives FDA Cleaning Validation Expectation: ECA

ECA Academy says a recent FDA Warning Letter “gives very nice insights into the state of the art regarding cleaning validation from the point of view of FDA.” The Warning Letter was issued 4/23 to Laboratoires Clarins, Pontoise, France.

The ECA analysis says the agency criticized that the company could not demonstrate that contaminants could be removed with the cleaning/disinfection procedures used. It says the only measure applied was visual inspection of surfaces.

In its response, ECA says, the company provided an overview of its cleaning validation strategy and timelines for implementation. FDA said the response contained too little specifics and no rationale for its cleaning validation approach. FDA requested:

an extensive plan evaluating cleaning/disinfection procedures and activities;
scientific rationale for the cleaning/disinfection validation strategy; and
a summary of cleaning/disinfection validation protocol updates including worst-case scenarios.

FDA also requested a summary of updated standard operating procedures to ensure that an appropriate program for verification and validation of cleaning/disinfection procedures was in place when requested, ECA reports.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome