FDA Policy/General

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.

Global Treat Srl, Galati, Romania (3/31): FDA inspected the firm 9/2019 and cited significant GMPs for finished pharmaceuticals. For example, Global Treat failed to perform, for each batch of drug product, appropriate laboratory determinations of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. Additionally, it failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. And it failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals. To view the letter, click here.

Mandelay Kft, Pest, Hungary (2/3): FDA inspected the firm 10/2019 and cited GMP deficiencies related to its Scientific Consciousness Interface Operation System and the Quantum University Energetic System Technology devices. For example, the company failed to establish and maintain adequate procedures to control the design of its devices in order to ensure that specified design requirements are met. Mandelay also failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. To view the letter, click here.

Philip Kennedy, Duluth, GA (2/27): FDA inspected the clinical investigator’s site 10/2019 and cited several human subject protection violations related to a undisclosed medical device study. For example, Kennedy failed to ensure proper monitoring and Institutional Review Board review and approval. He also failed to submit complete and accurate progress reports to the IRB. 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