While it seems like all of FDA is consumed with responding to the current COVID-19 crisis, the agency is still managing to continue its work in other areas. Earlier this week, FDA issued a final guidance, titled Nonbinding Feedback After Certain FDA Inspections of Device …
In a March 13, 2020 opinion, the United States Court of Appeals for the District of Columbia Circuit handed Eagle Pharmaceuticals, Inc. (Eagle) a significant win in FDA’s appeal from a District Court order requiring FDA to grant Orphan Drug Exclusivity to Eagle’s Bendeka (bendamustine) …
For the past two years, FDA has been working to improve the 510(k) Third Party Review Program. This program is meant to delegate the review of certain 510(k) submissions, freeing FDA’s limited resources to focus on the review of more complex devices and those that …
On December 19, 2019, the Federal Trade Commission (“FTC” or the “Agency”) filed a petition for writ of certiorari in the Supreme Court seeking review of a ruling by the Seventh Circuit case FTC v. Credit Bureau Center, LLC. A detailed overview of the background …
For those following the war between the Food and Drug Administration (“FDA”) and industry over the regulation of vaping products, last week’s opinion by the United States Court of Appeals for the District of Columbia Circuit upholding FDA’s so-called Deeming Rule is yet another battle …
It is generally accepted that FDA’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) does not allow for FDA to regulate the practice of medicine. FDCA § 1006 (21 U.S.C. § 396) explicitly states that FDA may not interfere with the practice of medicine …
In a decision that could dramatically change the course of how defendants conduct discussions with the government, a district court judge in the District of Minnesota required a defendant in a False Claims Act (FCA) case to turn over to a qui tam relator the …
On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests. The guidance is meant to provide clarity on the Agency’s expectations for information to be submitted in a De Novo request and to ensure predictability and consistency for sponsors. …
In the August 21 split panel decision issued in Federal Trade Commission v. Credit Bureau Center LLC, the Seventh Circuit held that section 13(b) of the Federal Trade Commission Act (“FTCA”), 15 U.S.C. § 53(b), does not authorize an award of restitution. In overturning its …
The pharmaceutical industry has filed a lawsuit challenging a recently finalized rule from the Centers for Medicare & Medicaid Services (CMS) which requires drug pricing disclosures in television advertisements for certain prescription drugs and biological products (the Final Rule). In an effort to block the …
Last week FDA issued a final guidance, Unique Device Identification: Convenience Kits, which clarifies FDA’s interpretation of a convenience kit for purposes of UDI labeling requirements. We previously blogged on the draft version here. As our readers know, the unique device identification system regulations require …
FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection. Background Section …
You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change …
The recent government shutdown gave us some time to reflect on 2018, a year that was full of device-related posts. Inspired by the recent Academy Awards nominations, we are now listing our Top Ten Device Posts of 2018. Some are blockbusters, and others indie stories, …
FDA recently hosted a webinar on the final guidance regarding the Breakthrough Devices Program. The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.” See our previous post for a more in-depth …
