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FTC Settlement Silences Advertisers of Supplements Advertised as Effective for Children’s Speech Disorders; Settlement Silent on the Number of RCTs Required
…will be enjoined from making advertising claims for Defendants’ speech products unless they possess competent and reliable scientific evidence to support the claims. For the speech products, “competent and reliable…
FDA Issues Proposed List of Class II Devices for 510(k) Exemption – Focus on IVDs, Including Drugs-of-Abuse Tests
…some over-the-counter tests. The proposed exemption for drugs-of-abuse test systems is limited to “test systems intended for employment and insurance testing and does not include test systems intended for Federal…
It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2
…marketing authorization for a non-PCR based test to detect SARS-CoV-2. The authorization of this De Novo, with a formal classification of Class II, now opens the door for follow-up 510(k)…
Patent Settlement Agreements: The Next Barrage
By Kurt R. Karst – In our recent post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning…
Seventh Circuit Rules That FTC Act Does Not Require Placebo-Controlled, Double-Blind Testing for Consumer Products
…criteria that evidence must meet in order to be deemed reliable, other than to note that “a statement that is plausible but has not been tested in the most reliable…
Bayer Case Highlights the Importance of Involving an Expert in Substantiation
…FTC case law beyond this order – defines “competent and reliable scientific evidence” specifically based on the “expertise of professionals in the relevant area.” (The Bayer 2007 order defines “competent…
CDC Opioid Prescribing Guidelines; Excluding Stakeholders is Wrong Path
…component within the U.S. Department of Health and Human Services, is developing guidelines “to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary…
Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)
…of FDA’s factors above and, yet, not be able to pass this translational test because there may no prior drugs developed to demonstrate the animal model’s translational ability. Such circumstances…
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…
The Court of Appeals for the D.C. Circuit Upholds FDA’s Deeming Rule
…of free samples. As we previously blogged here, on the same day FDA issued this final deeming rule, Nicopure Labs, Inc. (“Nicopure”) filed a complaint in the D.C. District Court…
FDA Issues “Receipt Date” Guidance for Electronic Submissions; Make Your Submissions Before Midnight With Time to Spare
…last to arrive is transmitted to the ESG and that transmission is completed at 11:55 pm EST, but that ANDA does not completely arrive at CDER until 12:01 am EST…
FDA’s Latest Lists for Digital Health Technologies
…device name, company name, lead review panel (e.g., radiology or cardiovascular), and primary product code. They provide a search bar to help find specific products and also include options to…
180-Day Exclusivity – From Abacavir Sulfate to Zolpidem Tartrate
…list. Like all things Hatch-Waxman, it is quite complicated and takes a lot of time to figure out. Imagine, if you will, coming across a cache of 5,000-piece puzzles in…
Obama Pledges To Open Borders for Personal Importation of Prescription Drugs
By Douglas B. Farquhar – More than nine years after passage of federal legislation that would permit individuals to legally import prescription drugs from Canada, the Obama Administration appears ready…
NIH Intends to Open New Manufacturing Facility by End of October
…FDA in May of its April decision to close the NIH Pharmaceutical Development Section (PDS) facility; NIH currently has not determined whether or when it will attempt to re-open the…