Multiple Antiseptic Wash Ingredients May No Longer Be Marketed-FDA Issues Final Rule

FDA has “issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than…

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FDA Grants More Time for Certain Unique Device Identifier (UDI) Requirements

FDA recently finalized a “guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.” Click to access the full story from RAPS Regulatory Focus, the Federal Register Notice (81 FR 59638), the new…

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FDA Requires Boxed Warnings to Address Combination Use of Opioids/Benzodiazepines

In making its announcement FDA Commissioner Robert Califf, M.D. stated that “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together…We implore health care professionals to heed these new warnings and more carefully and thoroughly…

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Is it a Drug, Device or Biologic? FDA Announces Changes to Request for Designation Program

In case you need a regulatory refresher, the Request for Designation is the formal process to determine which Center will conduct premarket review and regulate a combination product (See Guidance for Industry Office of Combination Products April 2011: How to Write a Request for Designation). Recently, FDA announced through FDAVoice that changes to the program…

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Latest Rx-to-OTC Switch: Prescription Veramyst® now OTC Flonase® Sensimist Allergy Relief

FDA recently approved another Rx-to-OTC switch. Formerly available by prescription only, Veramyst® will now be known for the purpose of OTC marketing as Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray). Sensimist™ (NDA 022051/S-013) is approved to treat symptoms associated with seasonal and perennial allergies. Read the full story here. The path to the…

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