Earlier this month, Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) introduced a new bill seeking to overhaul FDA operations and make it easier to introduce drugs and devices into the marketplace.
The “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act” (or RESULT Act) would make three major changes:
While Sen. Cruz says the proposed changes will “unleash life-saving drugs and devices in the United States,” former FDA official and FDA Group consultant Larry Stevens revealed some major shortcomings of the ideas in a recent article published by the Regulatory Affairs Professionals Society.Continue Reading
From drugs to medical devices to nutraceuticals and imports, the FDA inspects all manufacturers that produce products to GxP standards for compliance.
Under the Federal Food, Drug and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years––even more for companies just getting started, those with a history of compliance problems, and those who have started producing products significantly different from what they produced before.
With a stepped effort by the FDA to monitor the growing number of manufacturers entering the market, many new companies struggle to understand what to expect and how to prepare when inspectors show up at their door.
While the FDA’s Investigations Operations Manual offers the best complete resource for preparing to host an inspector auditor, or any other compliance specialist, we’ve summarized a few of the basic things to prepare for no matter what manufacturing space you’re in.Continue Reading
As drug and supplement companies increasingly turn to platforms like Twitter and Facebook to engage with patients and customers, it’s clear the FDA is actively monitoring what’s being said on these platforms just as they track communications on corporate websites.
In 2013, the supplement firm AMARC Enterprises made headlines when it was hit with a warning letter from the FDA for “liking” a post a customer left on the company’s Facebook page which praised the company’s supplement for warding off cancer without chemotherapy or radiation. To the FDA, the company’s “like” constituted an unauthorized drug claim.
With such a strong precedent set, companies are now wondering what it means for other social platforms like Twitter. Specifically, how do you ensure communications are compliant with regulatory standards in 140 characters or less?
To answer that question, we’ve broken down the three ingredients of a compliant tweet––a formula you can adapt to your own social media strategy. Before we get to that, however, let’s briefly look at the FDA’s guidance on social media use and how it applies to the microblogging site Twitter in particular.Continue Reading