The American Conference Institute’s (“ACI’s”) “FDA Boot Camp: Drugs & Biologics Edition” – now in its 30th iteration – is scheduled to take place from September 13-15, 2017, at the Omni Parker House, in Boston, Massachusetts. The conference is billed as the premier event to …
A citizen petition (Docket No. FDA-2017-P-2626) recently submitted to FDA asks the agency to exercise enforcement discretion with respect to the regulatory prohibition on interstate shipments of milk products that have not been pasteurized (21 CFR 1240.61). There have been previous petitions asking FDA to allow the …
In a new paper, titled “The Drug Innovation Paradox,” Professor Erika Lietzan of the University of Missouri School of Law (and a friend and fellow Hatch-Waxman addict) examines the relationship between the incentives offered under the law to develop drug products and the research and …
Earlier this week, the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee released a “Manager’s Amendment” to S. 934, the FDA Reauthorization Act of 2017 (“FDARA”). The 171-page Manager’s Amendment, which is slated for a HELP Committee vote later this week, includes several riders …
Every once in a while we come across an instance in which FDA’s Paragraph IV Patent Certifications List does not comport with our own 180-Day Exclusivity Tracker. Either the date on FDA’s list is different from the date we have (perhaps because of a change …
As simple as it may seem, counting can be a difficult human endeavor! You need only recall Monty Python’s Holy Hand Grenade of Antioch skit to cement that fact! Over the years we’ve commented (e.g., here) on the difficulty with counting to 60. That’s the magic …
FDA has historically classified accessories in one of two ways: (1) according to the parent device’s classification (either by express inclusion in the classification regulation or by clearance or approval of an accessory under the parent device’s classification regulation); or (2) by establishment of a separate …
The latest issue of FDLI’s Update Magazine features an interview conducted by Hyman, Phelps & McNamara, P.C.’s James E. Valentine. In the interview, James Valentine talks with rare disease patient advocate Christine McSherry about patient engagement in the drug development and approval process, focusing on …
FDA has again decided to delay the compliance date for its regulations governing calorie labeling for menus and menu boards at restaurants and similar retail food establishments. In an unpublished Interim Final Rule (IFR) released on May 1 (and scheduled to be published in the …
Last week, the Texas Department of Criminal Justice (“TDCJ”) filed an Amended Complaint in a case initially filed against FDA in January 2017 in the U.S. District Court for the Southern District of Texas. TDCJ initially challenged FDA’s delay in determining the admissibility, into domestic …
