FDA Policy/General

Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Acella Pharmaceuticals, Alpharetta, GA, (8/14): FDA inspected the firm in January and found significant GMP violations for finished drugs. For example, Acella failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures. It also failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. To view the letter, click here.

Mylan, Sangareddy District, India (8/20): FDA inspected the company in February and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, Mylan failed to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API. It also failed to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before reuse. To view the letter, click here.

Revival Products, Kernersville, NC (8/14): FDA inspected the firm in February and cited GMP violations for dietary supplements. For example, Revival failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution. The company also failed to make and keep complaint records. And it failed to make and keep documentation of training, including the date of training, type of training and persons trained. To view the letter, click here.

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