Wednesday, October 29, 2014

FDA LAW Blog: October 28, 2014 FTC and Bayer Head for a Show-Down By Jennifer M. Thomas –

Around this time last month, we wrote about the government’s motion for an order to show cause in United States v. Bayer, and the potential lessons to be gleaned from that case.  Bayer entered into a consent decree with the FTC in 2007, which prohibited the company from making any representation about the benefits, performance, or efficacy of a dietary supplement without “competent and reliable scientific evidence” to substantiate such claim.  The current proceedings arise from FTC’s assertion that Bayer lacks such substantiation for its representations about its probiotic product Phillips’ Colon Health.   Now it is time to briefly update our readers, as the saga of Bayer continues.  more

Tuesday, October 28, 2014

Important Stats: FDA Expectations for 503B Outsourcing Facilities

Posted: October 27, 2014 Human Hair Leads to Recall of Lidocaine HCI Injection

Minutes from 9/18/14 Hawaii Board of Pharmacy Meeting--discusses DQSA and office use

09.18.14 Pharmacy - Meeting Minutes - Hawaii.gov

hawaii.gov/dcca/pvl/boards/pharmacy/.../140918%20%20min.doc.pdf
6 days ago - compounded drug products as a matter of federal law. The DAG ... 147, a physician assistant authorized to prescribe drugs under Chapter 147A, or an advanced.

FDA Orders New Jersey Company to Destroy Unapproved Drug Products

Federal authorities have ordered a New Jersey company to destroy its unapproved products and stop further manufacturing and distributing them until the drugs receive Food and Drug Administration (FDA) approval. A federal judge from the US District Court for the Southern District of Ohio entered aconsent decree for a permanent injunction against the company, Ascend Laboratories of New Jersey. The unapproved drugs are as follows:

  • Pramoxine-HC Otic Drops;
  • Hydrocortisone Acetate Suppositories 25 milligrams;
  • Urea Cream 39%;
  • Urea Cream 40%; and
  • Urea Lotion 40%
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