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Posts tagged with "Regulatory Affairs"

  • Regulatory Affairs

    Tales From FDA Site Inspections

    It’s a summer Friday, so I’ll just send along this link to a story at Wired. It’s similar to this recent post, in that it details some of the ridiculous ways that small overseas manufacturers have tried to get around FDA site inspections. As a correspondent noted, though, the title of the Wired article isn’t… Read More
  • How Not to Do It

    Got It All Ready For You, Mr. FDA Inspector

    Many folks outside of this industry don’t realize that the FDA sends inspectors to drug manufacturing facilities in other countries. That might sound a bit odd, but agreeing to such inspections is in fact a condition of being able to sell pharmaceutical substances in the US (or to supply other companies that do). It’s a… Read More
  • Drug Prices

    Catalyst Sues the FDA

    So now we have another couple of twists in the Catalyst/Jacobus story (for background see these earlier posts). Jacobus, now that their version of amifampridine (3,4-diaminopyridine) has been approved by the FDA, has announced their price for the drug. And it’s definitely not the price they had before, which was free to the few people… Read More
  • Alzheimer's Disease

    A Missed Alzheimer’s Opportunity? Not So Much

    The Washington Post made quite a splash with this story about Pfizer, Enbrel (etanercept), and Alzheimer’s disease. There’s already been a lot of comment about it yesterday on Twitter and in some other venues, but I thought it might be useful to try to sum things up in an easily accessible place. Here we go: Read More
  • Business and Markets

    Catalyst and Jacobus and LEMS: The Latest Chapter

    I last wrote about the situation with Catalyst Pharmaceuticals here last December when Firdapse, their drug for Lambert-Eaton myasthenic syndrome, was approved by the FDA. If you know the story, though (or follow the links in that post) you’ll see that referring to it as “their drug” is a rather legalistic way of looking at thing… Read More
  • Regulatory Affairs

    A New FDA Commissioner, Suddenly

    The big news late yesterday afternoon was the resignation of Scott Gottlieb as FDA commissioner. I have no idea why he’s leaving, naturally. He’s spoken about wanting to spend more time with his family and being dissatisfied with going back and forth between Connecticut and DC, and I have no doubt that both of those… Read More
  • Business and Markets

    Breakthroughs, Sort of

    We’re all familiar with the FDA’s “breakthrough” designation for drugs (and drug indications) in the clinical trial/approval process. Opinions vary on the whole idea – useful way to prioritize regulatory attention, PR device for all involved because they’re handing ’em out like Halloween candy these days, o… Read More
  • Regulatory Affairs

    The FDA and the Dietary Supplements

    I’ve been complaining for years on this blog about the “dietary supplement” industry, which exists in its present form thanks to Sen. Orrin Hatch. That’s the 1994 “Dietary Supplement Health and Education Act”, which like many a federal bill has a name that is somewhat detached from reality. I would suggest the &# Read More
  • Business and Markets

    The Clinic Giveth And Most Definitely Taketh Away

    There have been some pretty dramatic clinical trial results coming out recently, and unfortunately drama is a variable that can take either a positive or a negative sign in front of it. On the plus side, MacroGenix, a company that not many people had been paying attention to, announced results of a head-to-head trial of… Read More
  • Drug Development

    2018 Drug Approvals: A Closer Look

    Let’s have a look at the recent new drug approvals. 2018 was quite a year, by the numbers. C&E News has a comprehensive roundup: 59 approvals (versus 46 in 2017, which was already a record by itself), and about two-thirds of those small molecules. There are some very interesting molecules in the list, and I… Read More
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