Drugs

Statistical Analysis of FDA Warning Letters

In a Food & Drug Law Institute review of Warning Letters (WLs) issued by FDA since 1/9/2020, a Hyman, Phelps & McNamara attorney and a regulatory expert say Tuesdays are the most common day for a WL to appear on the FDA Web site. The analysis found that over 71% of the 3,678 WLs that were reviewed were posted on a Tuesday, followed by nearly 12% that were posted on Thursdays.

“While we haven’t discovered any rationale behind this timing,” the authors write, “Tuesday has long been the favored day for posting WLs.”

The report says that on average, it takes 19 days from the date of issuance of a WL to being posted online.

The analysis found that the length of time between an inspection or other agency activity and the issuance of a WL “varies significantly, ranging from 0 to 239 days.”

The authors say their analysis showed an average of 124 days elapsing between the end of an inspection and WL issuance. “Three to four months is consistent with industry experience,” they write, “but inconsistent with the internal procedures outlined for FDA employees. Under FDA’s written procedures, one would expect WLs to be issued roughly 30 working days after completion of the inspection. Given that WLs are issued on average 124 days after an inspection, companies should not interpret the absence of a WL within 30 working days as meaning that no WL is forthcoming. Rather, they should look to observations in the form FDA-483 and other WLs to aid in predicting whether they are likely to receive one themselves.”

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