Drugs

Many Regs Proposed for Elimination or Change

Pharmaceutical industry stakeholders are telling FDA about many regulations they believe could be eliminated or modified in the interest of reducing administrative burden and improving efficiency. In a 127-page response, Pharmaceutical Research and Manufacturers of America lists 41 topics under three overriding categories — manufacturer communications and prescription drug labeling, general issues, and good manufacturing practice and related issues.

In its letter, the American Society of Clinical Oncology submits lists of things it believes are working well to support progress in cancer care and drug development, and things where improvements could be made.

Johnson & Johnson says its seven priorities that would enhance regulatory efficiency without comprising the company’s or FDA’s commitment to patient safety are: communication of information about medical products, post-approval regulations that allow changes to a label without FDA approval, advisory committee membership, electronic labeling of drugs and medical devices, quality metrics data, electronic records regulations, and medical device progressive approval.

Abbott submits a chart with items for revision or elimination. And the Consumer Healthcare Products Association submits a chart with recommendations on advisory committees, annual reports, import and expert requirements, quality metrics, medical device reporting, and many other topics.

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