Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections. As COVID raged, FDA understandably postponed many GMP (Good Manufacturing Practice) and “Bi-Mo” (Bioresearch Monitoring, usually of sponsors of clinical trials …
Thanks to years of watching @eavoss of New Rockstars, we have a pretty good handle on the Marvel Cinematic Universe (“MCU”). We know that Earth-199999, known in-universe as Earth-616, is the designated universe number for the main MCU; that there are a multitude of other …
Over the past few years, this blogger – in prior blog posts (here, here, here, and here) and in Congressional testimony – has been pretty critical of efforts to significantly revise and weaken the 180-day generic drug exclusivity incentive and framework first established with the passage of the 1984 …
On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT (here). NIPT are intended to screen for genetic abnormalities in a fetus. The tests are not intended to diagnose any genetic conditions – …
On Monday May 9, 2022, FDA issued an “update” announcing that it had sent 11 Warning Letters to companies that distributed dietary supplements alleged to be adulterated because one or more ingredients in the companies’ products contained an illegal dietary ingredient. (Two days later, one …
Hyman, Phelps, and McNamara’s Sara Koblitz will be presenting at the DC Bar’s annual webinar, “FDA for IP Lawyers” on May 25, 2022 with Brian Malkin of McDermott, Will, and Emery. The webinar will provide practical tips for integrating FDA regulatory law into IP law practices …
As one of several means to alleviate the ongoing shortage of infant formula in the U.S., earlier this week FDA issued a guidance document that outlines the factors FDA will consider in deciding whether to allow the distribution of an infant formula that does not …
Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. The final rule, which was set to go into effect on January …
We’re in the midst of UFA (User Fee Act) season! It’s the quinquennial event when many of the UFAs are up for reauthorization. And with “must-pass” FDA legislation, comes a host of riders—pieces of FDA-related legislation not specific to UFA reauthorization, but that folks seek …
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add a 2nd to 5th year associate to its enforcement and litigation team. Our team investigates and defends against threatened enforcement actions by government prosecutors and regulators, including the FDA and DEA. Types of matters include: Representing clients in …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be speaking on an expert panel at the 20th Advanced Summit on Life Sciences Patents, which is being held virtually and in-person in New York City on June 2-3, 2022. Ms. Gaulkin will join speakers …
A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion. Of interest (to me) is the DTC communication cited where OPDP, …
Last week, Attorney General Merrick Garland reiterated the position expressed during his confirmation hearing that enforcement of marijuana cases in states where activities are legal is an inefficient use of Department of Justice (“DOJ”) resources. Responding to Senator Brian Schatz (D-Hawaii) during a Senate Appropriations …
