Drugs

Product Quality Microbiology Info MAPP

The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures, Product Quality Microbiology Information in the Common Technical Document—Quality (CTD-Q), to assist CDER product quality microbiology reviewers by providing the expected locations of product quality microbiology information in the CTD-Q format. The document says the CTD-Q format differs considerably from the previous format used by firms to submit product quality microbiology information and thus reviewers need assistance on locating critical product quality microbiology information in applications submitted in that format. The document says reviewers should look in Attachment A, which lists the CDT-Q sections that apply to microbiology, for three cross-references, and Attachment B, which is the table of contents of the sterilization process validation guidance, for cross-references to the CTD-Q. The document is a revision and is substantially unchanged from the original 2004 version. The current update includes “Administrative changes made to reflect organization changes from Office of Pharmaceutical Science to Office of Pharmaceutical Quality and to update MAPP format.”

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

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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