Drugs

Stakeholders Suggest Regulatory Science Topics

Generic drug stakeholders have recommended regulatory science research topics for FDA to pursue in Fiscal Year 2019. The Association for Accessible Medicines suggests: orally inhaled products, in-vitro methods, biowaivers, global reference product, CQAs, human factors considerations for sameness, identifying in-vitro alternatives to clinical endpoint studies, assessment of suitability of existing in vitro bioequivalence tests, combination drug device products, and drug product formulation.

The National Institute for Pharmaceutical Technology and Education calls on FDA to consider ways to improve awareness of the need for attention on adequate education, training, and experience for all aspects of generic drug development and regulatory approval process. It gives some specific recommendations for the agency to consider.

Perrigo responds to questions posed at a 5/24 FDA public workshop. The comments relate to (1) the effect on generic drug formulation of business-related decisions that involve Q1/Q2 or not and (2) the degree of device sameness and performance for complex combination products.

Finally, Teva says it believes FDA and industry “can better utilize existing technologies and regulatory pathways to further streamline generic drug development. It calls on the agency to:

review and update, where appropriate and backed by scientific research, all guidances that call for clinical endpoint studies to ensure they recommend the most efficient and relevant techniques and methodologies;
leverage data already available to reduce to reduce in vivo requirements; and
ensure that recommendations based on academic research are realistic and accessible to industry.

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