Drugs

Comments on ICH RWD Studies Guidance

The Association for Accessible Medicines (AAM) says it recognizes that the International Council for Harmonization M14 draft guidance on general principles on plan, design, and analysis of pharmacoepidemiological studies that use real-world data for safety assessment of medicines “includes recommendations and high-level best practices for the conduct of observational (noninterventional) pharmacoepidemiological studies that use fit-for-purpose data for safety assessment of medicines.” In its comment letter, AAM says the types of data that may be fit-for-purpose will vary depending on multiple factors, including whether the regulatory safety question pertains to a newly-approved drug, or whether there exists an established safety profile for a drug that has been marketed for some time.

The association recommends that regulatory authorities provide opportunities for applicants to consult with the regulatory authority early in protocol development to ensure that the study will generate appropriate, acceptable results.

AAM also provides specific line-by-line edits and comments, as does the Biotechnology Innovation Association.

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