Drugs

LeeSar Violating Outsourcing Requirements: FDA

An FDA 2/18 Warning Letter says that LeeSar, Inc., Fort Myers, FL, which registered as an outsourcing facility 4/30/14, was inspected from 7/3-7/12/17 and it was determined that the firm’s drug products failed to meet the conditions under section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain requirements of the act. The agency investigators also found deficiencies in the firm’s practices for producing sterile drug products that put patients at risk. Specific violations were:

misbranded drug products;
failure to report the specific drugs produced in each six month period; and
failure to submit adverse event reports.

The letter says that most of the firm’s proposed corrective actions appear to be adequate but some concerns still exist. LeeSar was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step, and a schedule for completion of the actions.

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