Drugs

Megafine Pharma CGMP, Data Integrity Issues

A 9/19-9/23/16 FDA inspection at Megafine Pharma, Mumbai, India, found significant deviations from current good manufacturing practice (CGMP) for drugs, along with data integrity concerns. A 2/24 Warning Letter says specific deviations included:

failure of the quality unit to exercise its responsibility to ensure that the drug manufactured comply with CGMP and meet established specifications for quality and purity;
failure to establish and follow adequate written procedures for cleaning equipment and its release for use in API manufacture, and to maintain adequate records of major equipment usage;
failure to ensure all specifications and test procedures are scientifically sound and appropriate to ensure that the company’s drugs conform to established standards of quality and/or purity; and
failure to control the issuance, revision, superseding, and withdrawal of all documents by maintaining revision histories.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity if data to support the safety, effectiveness, and quality of the drugs it manufactures. Megafine was told to provide (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a management strategy for the company that includes details of its global corrective action and preventive action plan.

The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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