…how many comments were actually logged in; on December 7, FDA showed 19,655 comments, and the next day 6,732.) While some comments were boilerplate, others were comprehensive, detailed critiques of…

…the new website. In response to common complaints from industry, FDA has adopted a new resource for PSGs, a dynamic web page entitled “Upcoming Product-Specific Guidances for Complex Generic Drug…

…other things, a group of letters sent by the U.S. House of Representatives Energy and Commerce Committee Oversight and Investigations Subcommittee and the U.S. Senate Finance Committee to myriad public…

Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones…

…the Dot Com Disclosures since May 2011.  According to Mary Engle (Associate Director, FTC Division of Advertising Practices), the FTC is accepting written comments on the issue through July 11,…

…thus, the CBO cost estimate) has oversimplified the analysis in a way that has material bearing on its utility and reliability for predicting generic entry or estimating costs under alternative…

…explanation of how these factors explain the increase. Itemized cost for production and sales, including manufacturing costs, annual marketing and advertising costs, total research and development costs, total costs of…

By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance…

…in the Act, please contact: Michelle L. Butler, mbutler@hpm.com, 202-737-7551 Alan M. Kirschenbaum, akirschenbaum@hpm.com, 202-737-4283 Jeffrey N. Wasserstein, jwasserstein@hpm.com, 202-737-9627 David C, Gibbons, dgibbons@hpm.com, 202-737-4286 Serra J. Schlanger, sschlanger@hpm.com, 202-737-4593…

…costs,” and “[a]ny data submitted to foreign government authorities to support drug pricing determinations;” and (2) “[d]ata that show which foreign development costs were recovered through cost recovery procedures that…

…cost-benefit analyses for proposed and final regulations.  This was very timely, coming just as I was slogging my way through the Office of Management and Budget’s (“OMB’s”) 2013 draft report…

…companies provided patients with access to FDA-approved birth control. In October 2022, the Committee issued a report titled “Barriers to Birth Control: An Analysis of Contraceptive coverage and Costs for…

…2002 through 2014, she directed the administering of prohibited substances to the horses she trained prior to over forty separate horse races at the Penn National Race Course in Grantville,…

…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…

…this analysis. The more familiar and simpler market comparison approach may be used if cost data are unavailable, but cost data will typically be available from the third-party consulting firms…