Drugs

Withdraw Drug Dissolution Guidances: Researcher

Retired Canadian health researcher Saeed Qureshi is asking FDA to withdraw guidances and related recommendations about assessments of drug dissolution characteristics of drug products such as tablets and capsules. In a 10/1 petition, Qureshi asks for removal of three specific guidances from 1997, 2017 and 2018, and the dissolution methods database.

While CGMP requirements say that all equipment used for drug product manufacturing must be validated to demonstrate that the equipment or testers are qualified and validated for the intended use and purpose, the petition says, drug dissolution testers have never been validated for their intended use. “Regulatory authorities (including FDA), pharmacopeias (including USP), manufacturers and/or suppliers of the products and the testers do not maintain or provide any supporting documentation in this respect,” it says…. “It is not possible for an analyst to obtain valid or accurate dissolution results/characteristics of any product, hence its quality. Thus, the consumers/patients have been receiving false assurance about the quality of the manufactured products.”

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