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A Final LDT Rule in April!? Will FDA be Prepared?
…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…
Disclosures in a Small Space: The FTCâs Revisions to .Com Disclosures
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…
Google to pay $500 Million Regarding Pharmacy Advertising; What is Next?
…process, has “stringent standards” against the issuance of prescriptions based on online consultations, and does not certify Canadian online pharmacies. Google also hired a third-party company to detect pharmacy advertisers’…
COPPA at 16
…under 13; and Companies that have actual knowledge that they are collecting PI via another company’s website or online service that is directed to children. If a company is covered…
Court Issues Ex Parte Temporary Restraining Order to Halt the Marketing of Acai Berry Weight-Loss Pills and Colon Cleansers
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) held a press conference in Chicago to announce a lawsuit against several companies, including Central Coast Nutraceuticals, iLife, Simply…
FTC Could Revise its Dot Com Disclosures Guidelines by Fall 2012
…There were a few presentations that included research and data on how consumers read disclosures online, and the innovative techniques that some companies are creating to effectively communicate disclosures (including…
The Clot Thickens! Bloggers Beware! Congress Requests Information from Drug Rep. Website on Anonymous Postings Concerning Early ENHANCE Study Results
…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…
Thereâs a New Reporting Tool in Town
…complainant who, for example, submitted an unreliable or inadequately documented complaint to the Agency, CDRH now has committed to “follow-up communication” and a tracking system. This will allow submitters to…
âItâs In the Mailâ Will Soon No Longer Apply to DEA Registration Applications
…eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more effective for the agency and registrants. Requiring Online Submission of Applications for and Renewals of…
Facebook âPokesâ Pharma Companies, Telehealth, and Online Pharmacies
…of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021….
FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) Labeling
…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…
Further Musings about DEAâs âSuspicious Orderâ Proposed Rule: What Will a Registrant be Required to Report?
…ordered The order form number for Schedule I and II controlled substances The unique transaction identification number for the suspicious order, and What information and circumstances render the order actually…
DDMAC Digs Deep to Link Unbranded Websites to Violative Promotional Practices
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…
21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&Mâs Two Complimentary Webinars
…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…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…