Reading through the news, here were 9 articles that were worth a closer look. Continue reading
CHICAGO, IL – May 14, 2015
Today, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity. For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for industry insight.
“Smart data has arrived onto FDA inspections. We are proud to unveil Enforcement Analytics today, a much-needed innovation in the regulatory space for the thousands of professionals who work on keeping their manufacturing processes up to snuff for the FDA,” said Tony Chen, co-founder and CEO of FDAzilla. Continue reading
It has been quite a year for FDA 483s and Warning Letters. Here are the top 5 stories for 2013: Continue reading
FDAzilla was mentioned in a front-page story today in the Wall Street Journal. The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.
Current and potential investors of your company may actually be reading your FDA 483.
At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Continue reading
FDA is the only federal agency that touches the lives of every American several times every day. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12. Continue reading
Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. FDA Matters believes this is probably good—any intelligent discussion of FDA’s future requires a long-term perspective and a mastery of detail and nuance—both of which are in short supply during “sound bite”-oriented politicking. Continue reading
I was recently interviewed about orphan drugs for the British website, “pharmaphorum” and thought my readers might be interested. Here is a sample: Continue reading
FDA Matters has been wondering: when is the right time to start talking about the 2012 U.S. Presidential election and how it might affect FDA’s future? The best answer is: when Congress has finished its FDA policy work for the year. With the enactment of FDA user fee reauthorization legislation and a pending agreement on government funding for the first half of FY 2013 (starts October 1, 2012), it is now time to start talking. Continue reading
According to the New York Times, FDA collected more than 75,000 employee e-mails in an effort to identify leaks of confidential trade secret information. At some point, a narrow, possibly legitimate inquiry into a handful of scientists at the Center for Devices and Radiological Health (CDRH) turned into a massive e-mail surveillance of selected individuals and their contacts. Continue reading
So much is going on at FDA right now, that it is difficult to pick just one topic for this week’s FDA Matters. Instead, we are going to take a quick tour of some “hot spots” at FDA and how they might affect the agency over the remainder of the year and beyond.
Please read on…there is something for everyone in the topics covered.
The “Lost” FSMA Regulations. At the very end of 2010, Congress passed the Food Safety Modernization Act (FSMA). The law was intended to fundamentally re-set the term under which FDA acts to assure a safe food supply. It focuses on preventing problems, rather than fixing or limiting them afterward. FSMA provides the agency with new authorities and additional resources consistent with FDA’s role of overseeing a global food supply. Continue reading
Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the most important steps along the medical device regulatory pathway to market, and to explain the disparities between it and the clinical trial process for drug approval. Continue reading
It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s). After all, to maintain a good compliance profile, as well as an efficient operation, requires the ability to detect problems, determine the root cause and permanently eliminate the problems. Continue reading
The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with a good GMP consultant. Continue reading
Congress is to be congratulated on its progress toward passage of user fee reauthorization legislation. House and Senate-passed versions are being reconciled by staff, with a few fairly tough issues yet to be resolved. There is no apparent barrier to a final piece of legislation later this month or during July. Continue reading