Drugs

FDA Faulted for Late Product Identifier Guidance

Bristol-Myers Squibb is finding fault with FDA for issuing a draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA) close to the end of the enforcement discretion period. The company says that “manufacturers have been preparing for a number of years to comply with the DSCSA requirement of affixing a product identifier on each package and homogenous case. With only two months left to the enforcement discretion period, manufacturers cannot make changes to packaging equipment and modify artwork in order to accommodate recommendations put forth in this guidance.”

In its comment, the Healthcare Distribution Association says release of the draft guidance two months before the 11/27 product identifier deadline “has caused considerable consternation for trading partners who believed they had accomplished this element of DSCSA implementation (often months or years ago) and now must weigh the significant risks and costs of changing their labeling and packaging operations, again (and potentially a third time, if the Q&A is finalized with changes). Unfortunately, the assertion that the Q&A is in draft and not binding offers no remedy.”

The Association for Accessible Medicines says that while its members appreciate the additional clarity provided through the draft guidance and its question-and-answer format, they still have technical and clarifying questions.

The Biotechnology Innovation Organization says the draft “helps to answer common questions sponsors may have regarding use of product identifiers….” The association offers suggestions and feedback to help ensure the draft provides clear and effective guidance to all stakeholders and allows for sufficient flexibility to reduce the likelihood of rework and potential product delays and shortages.

The National Association of Chain Drug Stores offers specific comments on elements of the guidance.

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