Drugs

Five Observations at Dr. Reddy Telengana Plant

FDA has released the FDA-483 with five observations from a 3/5-3/9 inspection at the Dr. Reddy’s Laboratories active pharmaceutical ingredient (API) manufacturing facility in Medak, Telengana, India. The observations were:

failing to fully follow responsibilities and procedures applicable to the quality control unit;
failing to follow procedures describing the handling of written and oral complaints related to API materials;
failing to maintain buildings used in the manufacturing, processing, and packing of API finished materials in a good state of repair;
separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of API finished materials prior to release; and
failing to assure that equipment used in the production of specified APIs are always maintained and/or kept in/under proper conditions for manufacturing operations and to prevent the contamination of the products handled and/or processed in the equipment.

Earlier this year the agency released an FDA-483 with 13 observations following an inspection at another Dr. Reddy’s facility in India. And it expressed concerns about Dr. Reddy’s facilities in the UK and India on at least eight occasions in 2017.

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