FDA Proposes Rule to Change the IND Annual Report

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 […]

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It’s Elementary – FDA Guidance for Na, K, and P Labeling for Rx and OTC Products

Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking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 […]

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Moles Can Be Dangerous (and Not Just in Your Yard) – FDA Warns Consumers that Danger Lurks in Unapproved 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 […]

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Have Some Time?  Read FDA’s Expectations on How to Assure Drug Product Labeling Is Safe!

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, […]

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IPledge Isotretinoin REMS Prompts FDA Flexibility and Plea to Manufacturers

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 […]

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Another Walk Down Benzodiazepine Lane – Download from Previous Workshop

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, […]

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Ever See a PANDA In Real Life?  Of Course You Did – You May Even Own One!

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 […]

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Doctor holding a clipboard with Safety first, Medical concept

Changes to the Clozapine REMS will Take Effect on November 15, 2021 – Be Prepared

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 […]

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Businessman Looking At The End Of The Road

FDA Determination that Lorcaserin Was Withdrawn for Safety Reasons

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 […]

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