Drugs

2 Inspection Program Guides Revised

FDA says it has revised the following two compliance programs on inspections that are being implemented, effective 10/17:

CP 7346.832—Preapproval Inspections — the program guidance provides procedures involving NDAs and ANDAs; and
CP 7356.002—Drug Manufacturing Inspections — the program guidance provides procedures for GMP surveillance inspections at manufacturing establishments.

“The two compliance programs were primarily revised to add information regarding elements of International Council for Harmonization guidances for industry Q9 Quality Risk Management, Q10 Pharmaceutical Quality System, and Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; control of nitrosamine impurities; and alternative tools for evaluating facilities that are relevant to the inspection program,” the agency says.

Additionally, the recent reauthorization of the drug user fee program required the agency to revise “CP 7346.832—Preapproval Inspections” to fulfill a goal in the program’s commitment letter about the agency’s need to communicate with manufacturers at least 60 days in advance of a pre-approval inspection, and no later than mid-cycle during the application review, when FDA determines that it is necessary to conduct the inspection at a time when the subject product is being manufactured.

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

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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