Drugs

FDA Releases Immunomedics EIR

FDA has just released the Establishment Inspection Report (EIR) from an 8/6-8/14/18 inspection at Immunomedics, Morris Plains, NJ. The EIR says a 13-item FDA-483 was issued to the company at the close of the inspection with these observations:

the quality control unit lacks authority to investigate critical deviations of approved procedures;
there is no assurance that samples and batch records from a redacted intermediate process validation and commercial batches manufactured prior to 2/2018 were not impacted by the data integrity breach;
retesting procedure for the redacted intermediate is inadequate;
the raw material sampling and testing program is inadequate;
the firm lacks procedures for inventory audit trail and for tracking and reconciliation of raw materials used to manufacture the redacted intermediate;
differential pressure between GMP areas of different area classification is not adequately maintained and monitored;
design of the facility is inadequate in that no drains are present in the purification rooms and there is no SOP for liquid containment and disposal after a catastrophic spill;
there is no signed quality agreement between a redacted organization and Immunomedics;
no procedure is in place for redacted intermediate trending of results;
deviation investigations and CAPA implementation are inadequate;
deviation initiation and closing times are inadequate;
cleaning of downstream equipment is not validated or verified; and
the procedure to prevent contamination of the redacted intermediate is inadequate for a product stored under specified conditions.

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