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A Final LDT Rule in April!? Will FDA be Prepared?
…FY 2022, at 13-18, https://www.fda.gov/media/167825/download?attachment. [14] FDA, 510(k) Premarket Notification Search Database (last updated Nov. 13, 2023), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Searches were done for all IVD panels: immunology, microbiology, clinical chemistry, pathology,…
The Clot Thickens! Bloggers Beware! Congress Requests Information from Drug Rep. Website on Anonymous Postings Concerning Early ENHANCE Study Results
…the letter) “all records relating to any posting on Cafepharma.com related to the ENHANCE study, including but not limited to, names, addresses, phone numbers, and e-mail and internet protocol addresses…
FTC Could Revise its Dot Com Disclosures Guidelines by Fall 2012
…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,…
Disclosures in a Small Space: The FTC’s 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…
DDMAC Digs Deep to Link Unbranded Websites to Violative Promotional Practices
…recommended that physicians test their patients for “suboptimal” plasma levels through Avantix Laboratories. To add insult to injury, DDMAC determined that the Avantix website, www.bloodleveltesting.com, was registered to Novartis, its…
21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s 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…
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…
The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One)
…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…
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…
Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health
On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr., for Secretary of Health and Human Services (HHS). Although not altogether surprising, the formality of an official…
Highlights of Medical Device Related Provision in the 21st Century Cures Act
…products. If you have questions or need more information, contact: Jeffrey K. Shapiro, jshapiro@hpm.com, 202-737-9633 Jeffrey N. Gibbs, jgibbs@hpm.com, 202-737-4288 Jennifer D. Newberger, jnewberger@hpm.com, 202-737-4292 Allyson B. Mullen, amullen@hpm.com, 202-737-9639…
Tuesdays (and Thursdays) With Regulations.gov BETA
…2020 to June 10, 2020, from newer to older postings, under the “Documents” and “Comments” tabs, respectively. You just have to modify the dates in the URLs when you want…
FDA Amends Informed Consent Regulations
…after considering comments, adopted the final rule, which will become effective on March 7, 2011. However, FDA is providing a grace-period of 1 year, stating that the Agency intends to…
Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning
…safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses that sell consumer products—including food, cosmetics, and OTC drugs—notify Californians about possible…
Come Work for HP&M — Hosts of FDALawBlog.Net
…to waive into D.C. Bar). Compensation commensurate with experience. Excellent benefits package. Email resume to jwasserstein@hpm.com. For more information about the firm, see www.hpm.com. HP&M is an equal opportunity employer….