Being Comfortable in a World of Never-Ending Change
The <em>Quality Digest</em> Way Welcome to Quality Digest Daily 2.0! This new format represents a significant re-imaging of our flagship brand (the industry’s only daily newsletter), which...
View ArticleQuality Digest Interprets the Voice of the Customer
Our latest user survey offers a wealth of information and opportunities for improvement Last month I wrote an article entitled “Being Comfortable in a World of Never-Ending Change.” Editor in Chief...
View ArticleFDA, Industry Grapple with Similar Quality, Technology Challenges
FDA is making an effort to keep industry informed of its thinking With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward...
View ArticleShould Commitments Made to the FDA Be Taken Seriously?
There’s no excuse for poor responses or missed deadlines Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during...
View ArticleFDA Protects Us from Terror of Unpasteurized Milk
SWAT-style inspectors descend on small dairy farms and co-ops I don’t know about you, but I sleep easier now knowing that our Food and Drug Administration (FDA) has declared war on unpasteurized milk...
View ArticleWhen ‘Reason to Believe’ Halts Food Production
Sloppy record-keeping could trigger the FDA’s administrative detention As of July 3, 2011, the Food and Drug Administration (FDA) has increased authority to use administrative detention as an...
View ArticleThe Food Safety Modernization Act: A Public Health Imperative
Why the new legislation is necessary According to recent data from the Centers for Disease Control and Prevention, every year about 48 million people get sick, 128,000 are hospitalized, and 3,000 die...
View ArticleMisguided FDA Food Regulations Will Hike Costs, Not Safety
The FDA takes a closer look at sodium and advertising This year will mark another push for aggressive food regulation at the Food and Drug Administration (FDA). On tap, salt regulations and...
View ArticleWhat the Heck’s Going On at the FDA?
FDA caught spying on its scientists The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration...
View ArticleIs the FDA Better Off Than It Was Five Years Ago?
Many needed improvements are too logical for government comprehension During a debate with then-President Jimmy Carter, Ronald Reagan famously asked Americans if they were better off than they were...
View ArticleGive the FDA More Authority Over Compounding Pharmacies
They are currently protected from the big bad regulatory wolf Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have...
View ArticleRegulatory Science Is Not Boring
Seriously. Really. I’m not kidding. I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is...
View ArticleIt’s Time for the FDA and States to Step Forward for Public Health
It shouldn’t take nearly two years to conduct a compound pharmacy inspection It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will...
View ArticleHow Effective Are Flu Shots?
Sometimes 60% isn’t all it’s cracked up to be This flu season has been worse than normal. The Centers for Disease Control and Prevention (CDC) data show that the flu has struck early and hard....
View ArticleSave Us from Sprouts and Cilantro
FDA’s ‘Proposed Rule for Produce’ tidies up the dirty task of growing things On Jan. 4, 2013, the Food and Drug Administration (FDA) took the first step in its history to regulate produce farmers. The...
View ArticleSimple Nutrition Facts for Complicated People
Food for thought for winners of the fattest nation contest Nutrition labels have been much in the news lately, presumably because we have once again won the fattest nation contest. The Food and Drug...
View ArticleRaise a Glass to a Dumb Medical Device Tax Brewed in D.C.
Consumers, not companies, will foot the medical device excise tax A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and...
View ArticleKeeping Up With Mobile App Innovations
FDA to issue final guidance on apps that need approval A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he is having...
View ArticleA New Breed of Pharmacy Compounding Has Outgrown the Law
FDA must have new authorities to regulate these facilities The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself...
View ArticleGrow the Carrot, Chop the Tree
Medical-device product failure is a sequoia-sized problem in need of a quality management chain saw The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly...
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