…In addition to providing greater clarity around major deficiencies (i.e., mortal sins) that will generally result in an RTR decision and minor deficiencies (i.e., venial sins) that can be easily…

…residues, industrial chemicals, toxins, and nutrients present in foods to monitor changes in the levels of those substances and help the agency evaluate potential risks to public health.  Because the…

By Oisin A. Mulvihill* & Peter M. Jaensch – A recent string of high-profile pharmaceutical and medical device product recalls appears to be reigniting FDA’s interest in pressing misdemeanor charges…

…Asia-Pacific regional trade agreement being hammered out among the United States and eight other partners.  The TPP would cover trade in goods and services and also includes a proposed chapter…

…labeling and advertising enforcement actions, dietary supplement compliance issues, and ethical considerations when dealing with complex compliance issues.  You can access on-line registration and a brochure with additional information here….

…all of the details of the case; we’ve posted on it before on several occasions – see here, here, here, and here.  So here’s the bottom line from the Court:…

…for an approved drug product) to support approval” (italics in original). FDA’s petition response (like the Agency’s draft guidances) raises a host of unanswered questions.  For example, what series of…

…for OTC MIRALAX for the relief of occasional constipation.  After the approval of OTC MIRALAX, FDA removed all Orange Book references to NDA No. 020698 (prescription MIRALAX), and in April…

…other things, the PTO cites in its denial the Federal Circuit’s decision in Arnold P’ship v. Dudas, 362 F.3d 1338, 1341 (Fed. Cir. 2004), concerning a PTE denial for VICOPROFEN…

…proposed regulation would: Require states to convert to an actual acquisition cost basis for Medicaid prescription drug payment  Expand the MDRP to the U.S. territories Apply a statutory alternative rebate…

…generic version of a pre-1962 drug under the pre-Hatch-Waxman ANDA approval procedures, based on the 80,000 series application number).  On December 28, 1998, FDA approved Mylan’s ANDA No. 040298 for…

…FCC standards, proposes standards to be included as new FCC Appendix XV, titled “Microbial Food Cultures Including Probiotics.”  The proposed standards provide a broad description of microbial food cultures (“MFCs”). …

…for approval sketches of their labels showing all required label features and any special claims that the establishments intend to make, e.g., quality claims, natural claims, and nutrient content claims. …

…Avastin® for the breast cancer indication while Genentech designs and conducts additional studies intended to verify the product’s clinical benefit if the Commissioner agrees with certain grounds for withdrawal. FDA…

…is withdrawn does not confer any additional or special responsibilities or obligations on an ANDA RLD sponsor. Several of the points MGP makes in its comments to FDA are reiterated…