Tag Archives: FDA

Patients Suffering from Gaucher’s Disease Deserve Better

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Gaucher Disease is one of the over 6,000 rare diseases that affect patients worldwide, representing a frontier of unmet medical need [NCATS, NIH]. The challenges for drug development generally—long and costly research and development timelines—are exacerbated by the inherently small patient populations affected by rare diseases. These patients can be difficult to identify and geographically dispersed and their clinical presentation can be quite disparate, complicating the design and recruitment for clinical trials used to determine Read More >

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Pro-GMO Labeling Business Faces Own Labeling Dilemma

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 “Dr. Bronner’s should spend more time worrying about their own labels.” The Center for Consumer Freedom recently published an interesting piece on Dr. Bronner’s Magic Soaps and his run in with the FDA.  You may know that Dr. Bronner’s Magic Soaps is an outspoken advocate of the scientifically suspect “GMO labeling” movement.  In a warning letter to the company, the FDA states: “Based on our review of the product label, we have determined that your product is promoted for conditions that Read More >

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Docs to FDA: Biosimilars should have different names than branded drugs

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Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

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The “Other Issues to Worry About” vs. GMO’s

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We don’t label foods for pesticides, fertilizers or these other “conventional” food-production technologies. Only genetically engineered food is considered unconventional; it’s what the big labeling-law movement is all about these days. Why is that? Largely because groups of people have managed to make it an issue, not because it’s the one big dangerous thing happening with our food – The LA Times, Karin Klein Last week, the Los Angeles Times released an opinion blog with Read More >

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Forbes: Faster FDA Approvals Have Not Caused More Drug Safety Problems

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In 1992, Congress, industry, and the FDA worked together to create the Prescription Drug User Fee Act (PDUFA). This program ensures that FDA has the ability to hire additional reviewers to expedite the drug review process by having industry pay “user fees.” Recently, attention has been given to a flawed study in the August 2014 issue of Health Affairs, which has some critics claiming that PDUFA fees are biasing FDA review decisions. The study looked at Read More >

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