Drugs

Chewable Tablet Quality Attribute Guidance

FDA has published a draft guidance, Quality Attribute Considerations for Chewable Tablets, to give manufacturers of chewable tablets for human use CDER’s current thinking on the critical quality attributes that should be assessed during product development. The guidance also provide recommendations about submitting developmental, manufacturing, and labeling information for chewable tablets that must be approved by CDER before they can be distributed.

Recommendations in the document apply mainly to NDAs, ANDA, and certain CMC supplements. Some of the recommendations about submission of developmental information may also apply to INDs, it says. The recommendations about assessing critical quality attributes apply to all chewable tablets for human use, including non-application products.

An ideal tablet, the document says, should be easy to chew, palatable (taste masked or acceptable taste), of appropriate size and shape, and able to disintegrate readily to minimize aspiration and facilitate dissolution. Critical quality attributes identified in the guidance include hardness, disintegration, and dissolution, as well as all factors that may influence drug bioavailability and bioequivalence. FDA also says that careful attention should be given to tablet size, thickness, and friability, as well as taste. “No single quality characteristic should be considered sufficient to control the performance of a chewable tablet,” the agency says. “Instead, the goal should be to develop the proper combination of these attributes to ensure the performance of the chewable tablet for its intended use.”

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