What is a Quality Management System (QMS)? As a marketer or manufacturer of medical devices, you know that a quality management system (QMS) is critical to your success and continued operation. It doesn’t take more than one FDA inspection to figure this one out. If you are involved in, or considering entry into the medical…
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…
According to Kaiser Health News “As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, or GPhA. The FDA has approved more generics the past few years, but a flood of…
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the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.”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…
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…
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…
The revised user fees will go into effect October 1, 2016 and remain in effect through the end of September 2017. It is important to note that not all fees will be reduced, and some will increase. Following is an excerpt of the story, recently published in Regulatory Focus describing key changes: ANDA ($70,480, down…
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…
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…
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…