Drugs

FDA Releases Sun Form 483 After Latest Inspection in India

FDA has cited Sun Pharmaceuticals with an 11-item Form 483 after completing a week-long inspection 4/13 at the firm’s Dadra, India finished-dosage drug manufacturing facility. For example, FDA said the firm’s laboratory records do not include all calculations and graphs associated with a test. Additionally, the agency found that batch production and control records do not include an accurate reproduction of each appropriate master production or control record checked for accuracy and signed.

Sun has had its plate full in addressing inherited GMP issues from its acquisition of Ranbaxy Laboratories in 2015, which were under a consent decree at the time. In March, FDA notified Sun Pharma that it was lifting an import alert imposed on its Mohali (Punjab) drug manufacturing facility in India that was a legacy penalty under the decree (see story).

In December, an FDA inspection at a Sun facility in Halol, India, resulted in a 14-page FDA-483 list of observations. The agency also issued a Warning Letter to the Halol facility in 2015.

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