Drugs

PhRMA Supports Streamlined GMPs for Combo Products

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA’s efforts to identify alternative or streamlined mechanisms for complying with GMPs for combination products. In comments to an agency notice on the efforts, PhRMA sought additional clarity on certain elements of the mechanisms outlined in the notice, and “strongly encourage(s) FDA to adopt a more robust risk-based approach to determining exemptions of combination products from the device Quality System regulation (QSR).”

Specifically, PhRMA raised concerns with FDA’s proposal to allow sponsors to change a GMP mechanism to one that is different than one previously discussed with the agency. The group says it is “unclear how FDA will consistently apply this approach across the agency when, for example, a given GMP mechanism is described in guidance from multiple Centers or offices or is misaligned with current guidance. PhRMA urges the Office of Combination Products (with the cooperation of the appropriate reviewing bodies) to ensure that sponsors consistently have an opportunity to apply alternative approaches that are risk-based and scientifically justifiable.”

PhRMA says it also strongly supports FDA allowing combo product exemptions “from all or certain provisions of the device QS regulation (part 820) if the device constituent part of the combination product is itself exempt from such requirements and use of the device constituent part falls within the scope of the relevant exemption, including with respect to the device constituent part’s intended use.” The group says it previously conveyed its concerns with the “current combination product regulations with respect to drug products co-packaged in convenience kits with low-risk delivery devices (such as dosing cups, syringes, spoons, etc.), which may subject the drug manufacturer to the full QSR when such devices are included with a drug in a convenience kit.”

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