Drugs

Indian Drug Makers Want More FDA Transparency: Mylan

Mylan president Rajiv Malik says Indian drug companies are becoming frustrated with FDA’s lack of transparency in the process for resolving enforcement actions after a number of 2015 enforcement actions stopped new product approvals at many facilities. In an interview with Bloomberg News, Malik said that “there’s a general sense of frustration that maybe there can be a much better defined process with some visibility, because businesses need to make calls about how long they are under water, when they can hope to come out of it. The problem is there’s a process, but there’s no transparency about the process. There’s a timeline, but there’s no transparency about the timeline.”

He said that the Indian pharmaceutical industry is working with FDA to make resolution of regulatory issues more transparent. In 2013 Mylan bought Bangalore-based Agila Specialties and three of its facilities were among those receiving FDA Warning Letters over deficient manufacturing practices.

Malik told Bloomberg that the company had replaced the workforce at Agila and was training new employees from scratch to ensure that the deficient practices don’t continue.

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