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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog: Biosimilars

Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. And on X (R.I.P.

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FTC Continues to Rage Against Device Patent Listings in the Orange Book

FDA Law Blog: Biosimilars

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book. Because a “drug product” is defined by regulation as a “Finished dosage form.

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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?

Pharmacy Joe

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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Episode 575: Novel dosage forms that should not be crushed (but look like they can be)

Pharmacy Joe

In this episode, I’ll discuss novel dosage forms that should not be crushed but look like they can be. Episode 575: Novel dosage forms that should not be crushed (but look like they can be) Subscribe on iTunes , Android , or Stitcher Two relatively new dosage form technologies are nanocrystals and amorphous solid dispersions.

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Over-the-Counter Choices Pharmacist Role and Resources

FADIC

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. Its OTC drug section covers a broad range of OTC medications, offering detailed descriptions, recommended dosages, and potential drug interactions.

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Episode 990: Lowest Effective Dose of Haloperidol for Agitation in Elderly Patients

Pharmacy Joe

Secondary outcomes were the hospital length of stay, utilization of restraints, and discharge outcomes (to a facility when admitted from home) between dosage groups. The primary outcome looked at efficacy as judged by the need for repeat doses within 4 hours. The low, medium, and high dose groups had 15, 23, and 19 patients, respectively.

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