Compounding has recently undergone a regulatory overhaul by Congress and the FDA. In November 2013, the Drug Quality and Security Act (DQSA) was signed in to law, amending the federal Food, Drug, and Cosmetic Act (FDCA) and overhauling the regulation of compounding. In July 2014, the FDA released rules and guidances and other documents implementing […]
Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag.
Why are these approaches being ignored? Could it be because there is little profit to be made from them? Action Alert!
ObamaCare was crafted to suit the largest insurance companies, and now your tax dollars are subsidizing them.
One test per year not related to a specific illness under Medicare? So much for preventive medicine.
The USDA’s response is to talk out of both sides of their mouth. In a single press release, the USDA closes its investigation of the contamination of wheat fields in Oregon, calling it an “isolated incident,” then immediately contradicts itself by opening another investigation into contamination from genetically engineered wheat. The contamination was found at […]
The agency has responded to comments from ANH-USA activists and other stakeholders. Here’s what they’re proposing now. Action Alert! In May we reported that the FDA is currently drafting rules that implement the 2011 Food Safety Modernization Act (FSMA). As we noted then, some of the rules that have been proposed so far have brought […]
Dr. Einsteinburger, scientific director of Biosantech (no relation to any real biotech companies located in the St. Louis area), elaborates on the latest innovations by the leader in biotech.
Contrave has terrible side effects, is expensive, includes a hidden antidepressant, and barely even works. So why did the FDA approve it? Action Alert! The FDA approved two weight loss drugs in 2012, Qsymia and Belviq, but sales have been sluggish. This week FDA approved Contrave, even though the FDA initially denied approval to Contrave in […]
A powerful subcommittee says a new FDA proposal on medical testing will stifle innovation and may not be legal. Action Alert! Three months ago we told you about laboratory-developed tests (LDTs)—inexpensive diagnostic tests for patients that are developed and performed by local labs. They include standard tests but also new ones, genetic tests, tests for […]