Drugs

Latest FDA Warning Letters

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

Balamurali K. Ambati, Eugene, OR (8/13): FDA inspected the clinical investigator in April and cited Ambati for not adhering to applicable statutory requirements governing the conduct of clinical investigations. For example, Ambati failed to submit an IND for conducting clinical investigations with an investigational new drug. To view the letter, click here.

Haw Par Healthcare, Singapore (8/19): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, the firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures. To view the letter, click here.

Metuchen Pharmaceuticals, Freehold, NJ (8/16): FDA recently reviewed a direct-to-consumer print ad and display banners (see earlier story) related to erectile dysfunction drug Stendra (avanafil) tablets. The agency said the promotional materials make false or misleading claims about the risks associated with the drug. And, the labeling does not provide adequate directions for safe and effective use of the product. To view the letter, click here.

Polimeros y Servicios, San Jose, Costa Rica (8/22): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for drug products. It also failed to test incoming active pharmaceutical ingredients and other raw materials used to manufacture drug products to determine their identity, purity, strength, and other appropriate quality attributes. To view the letter, click here.

Yino, Inc., Chongqing Shi, China (8/12): FDA inspected the firm in March and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, Yino failed to transfer all quality or regulatory information received from the API manufacturer to its customers. It also failed to establish an adequate quality system and lacks quality oversight on documentation. 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