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 …
Our last post on the Eleventh Circuit’s September 2021 decision in Catalyst v. Becerra got a lot of attention. We’d like to think that this is because the scope of orphan drug exclusivity is as fascinating to everyone as it is to us, but if …
Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically. DEA issued a final rule on April 11, 2022, eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more …
On April 13, 2022, FDA released its long-anticipated final Guidance for Industry # 256 – Compounding Animal Drugs from Bulk Drug Substances (GFI). As readers of this blog likely remember, the animal drug compounding GFI has had a relatively long and tortured history, blogged about …
On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). MDUFA authorizes FDA to collect fees from certain medical device applicants …
The American Conference Institute (“ACI”) is hosting its 17th Annual Paragraph IV Disputes Conference in New York (and livestream) from April 26-27, 2022 (Eastern Daylight Time). Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and …
On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget. This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. …
One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible. This estimation …
With great sadness, we announce that our firm’s co-founder, leader, colleague and friend, Jim Phelps passed away on April 2, 2022, at the age of 83. Jim is survived by Sophia, his wife of 57 years, his three sons and their wives, Evan and Nicola, …
Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form. Instead, the amended loss regulations establish thresholds which will reduce the number of reports received by the California BOP, and in our opinion, creates …
In January 2021, we reported on a CMS rule that, among other things, revised the Medicaid rebate best price regulation to remove impediments to value-based purchasing (VBP) arrangements in Medicaid. The rule, which will go into effect on July 1, 2022, defined a VBP is …
It was some time ago that we posted on what we though was “the Good” in an avalanche of FDA-related legislation that we sorted into three categories: the Good, the Bad, and the Ugly. Our prior post took a look at a couple of bills …
