Biologics

Comments on Voluntary Recall Guidance

The Healthcare Distribution Alliance says it commends FDA for issuing a draft guidance on initiating voluntary recalls and the clarity and assistance it offers to recalling firms and their trading partners. It also says the draft is not aligned with Drug Supply Chain Security Act requirements and explains its detailed concerns.

The Center for Science in the Public Interest says the draft could be improved by clearly outlining the steps required for communications between a recalling firm and a retail consignee. The focus of its comments is on foods.

AdvaMed comments that the draft “provides a good overview of what a firm should consider when developing its recall processes and procedures.” The medical device trade group says FDA should determine that the definition used in the draft guidance applies for the purposes of Part 806 requirements for medical device recalls.

The International Society for Pharmaceutical Engineering says the guidance should be revised to provide context that a firm may need to interact with the agency to prepare its recall strategy before making external communications, such as public warnings. And it says the guidance should also be revised to address the possibility that a firm may need to interact with the FDA Office of Compliance or Division of Drug Shortage while it is developing its recall strategy for correction or removal of a life-saving or life-supporting medical product.

Finally, Apotex provided line-by-line technical comments.

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