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The Clot Thickens! Bloggers Beware! Congress Requests Information from Drug Rep. Website on Anonymous Postings Concerning Early ENHANCE Study Results
…VYTORIN’s market share. The most recent letter in this deepening controversy brings the online community into the fray. Specifically, on February 11, 2008, the U.S. House of Representatives Energy and…
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
…readers that Hyman, Phelps & McNamara, P.C. (“HP&M”) will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, January 18, 2017 from 12:00-1:30 PM (Eastern)….
FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) Labeling
…(Dec. 1, 2014) (to be codified at 21 C.F.R. § 101.11(a)) (emphasis added). In today’s final guidance document, FDA seems to take a more expansive view of this last factor than…
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…
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 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…
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…
Tuesdays (and Thursdays) With Regulations.gov BETA
…to create quick daily docket sheets. Here are example URLs: “https://beta.regulations.gov/search?agencyIds=FDA&postedDateFrom=06-09-2020&postedDateTo=06-10-2020&sortBy=title&sortDirection=desc” (for documents) and “https://beta.regulations.gov/search/comment?agencyIds=FDA&postedDateFrom=06-09-2020&postedDateTo=06-10-2020&sortBy=postedDate&sortDirection=desc” (for comments). These URLs search FDA docket entries on the Beta site from June 9,…
Come Work for HP&M — Hosts of FDALawBlog.Net
Hyman, Phelps & McNamara, P.C., the nation’s largest dedicated food and drug practice, seeks a mid-level associate experienced in drug/biologics development and approval for our D.C. office. The ideal candidate…
ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products
…receive a discount) at www.AmericanConference.com/Cosmetics, or contact Bolam Kim (B.Kim@americanconference.com) directly to attend. Please be sure to use discount code S10-866-866L16.S to register and receive 10% off the tuition fee. …
ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II: A Follow-Up
…a solution to companies that have discontinued ANDAs for drug products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com; and https://www.andarepository.com/) is offering what we can only characterize…