FDA Policy/General

UCLA Promoting Investigational Drug: FDA

The CDER Office of Prescription Drug Promotion (OPDP) says that a Web page and brochure issued by UCLA on the investigational new drug Gallium-68 (Ga68-PSMA) are suggesting in a promotional context that the drug is safe and effective for the purpose for which it is being investigated, or otherwise promotes the drug. “The claims in the Web page and brochure are concerning from a public health perspective because they make conclusory representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by FDA and whose safety and efficacy have not yet been established,” OPDP says in a 12/28 untitled letter.

The letter says the Web page and brochure describe Ga68-PSMA as a new option for use in PET scans to detect prostate cancer cells throughout the body. It recites a number of claims made about the drug in the promotional materials and says they suggest that it is a “new imaging test that accurately detects prostate-cancer cells throughout the body” that “represents a major advance in detecting prostate cancer” with “no common side effects or significant risks” and that “in contrast to traditional studies, PSMA-PET imaging offers high sensitivity and specificity” in “detecting the location of prostate-cancer recurrences.”

The letter directs UCLA to stop issuing violative promotional material for the drug and to reply with a list of all violative materials and a plan for discontinuing their use.

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