Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]
Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking on the standardization, proper format, and necessary information for the contents of these elements in OTC and prescription drug labeling. Right now, labeling for OTC products […]
The FDA issued a warning to consumers (here) that mole removal isn’t a DIY project and can be dangerous for a number of reasons. It warns that there is no FDA-approved OTC product for removing moles or skin tags. Unauthorized products, like those with a high‑level of salicylic acid, claiming to remove these lesions can […]
You may need some time to read this recently published guidance entitled, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (here), as it is 41 pages long. There is lots of good information contained in the document and, while it may contain most of what you know about labeling requirements, […]
The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male […]
We have done a number of posts on the FDA’s activities with regard to assuring the safe use of benzodiazepines (here, here, and here, where we discuss issues regarding increased warnings and potential REMs, and even the specter of abuse-deterrent formulations being applied to benzodiazepines (here)). While no one knows where this will end up, […]
In today’s prepublication of the Federal Register listing (here), there is a notice asking for stakeholder comments on the treatment of pre-1962 applications approved as ANDAs that were actually (unbeknownst to most) submitted under section 505(b) of the Act and approved under section 505(c) of the Act, like an NDA. The historical issues leading to […]
Clozapine was one of the first drugs to have a “REMS” system in place to ensure safe use such that patients developing clozapine-induced severe neutropenia were precluded from getting the drug, which would do further damage, and, thus, avoiding potentially life-threatening scenarios. Initially, the REMS program was independently operated by the innovator and, once the […]
In a podcast, FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm (here). The warning first came from FDA on March 25, 2021 in the form of a drug safety communication (here). The product marketed as Benzedrex is safe and effective when used in accordance with its […]
On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer. On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]
