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the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.”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…

Details
Types of FDA Drug Labeling

Types of FDA Drug Labeling and Their Requirements

Introduction FDA is charged with the duty of regulating the manufacture, sale and distribution of both prescription drugs and nonprescription drugs (aka over-the-counter or OTC medications).[1] A significant FDA role in the regulation of these medications is supporting sponsors in their efforts to ensure adequate drug product labeling. In this paper, we will describe the…

Details

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…

Details

FDA Issues New Draft Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device

Issued on August 8, 2016, regulatory impact includes the following: FDA issued the original Deciding When to Submit a 510(k) for a Change to an Existing 53 Device (K97-1) on January 10, 1997 to provide guidance on this regulatory language This draft guidance preserves the basic format and content of the original, with updates to…

Details

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…

Details

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…

Details
Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie?

Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie? 6 MUST READ SCENARIOS

As a prescription and OTC pharmaceutical consultant, I am repeatedly amazed by the successes resulting from the simplest of drug & device development ideas. While it may be legend, it is said that Charles H. Duell, Commissioner of the US Patent Office in 1899 coined the phrase “everything that can be invented has been invented.”…

Details